Microsoft Word - R Field Safety Notice_eng

Smith & Nephew Inc T +1 901-396-2121 1450 Brooks Road www.smith-nephew.com Memphis, TN 38116 [Recipients Address] August 29, 2016 URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action / Recall Reference: R-2016-32 Concerned Devices: TANDEM BIPOLAR HIP SYSTEM Product No. 71322040 71322041 71322042 71322043 71322044 71322045 71322046 71322047 71322048 71322049 71322050 71322051 71324059 71325039 71325040 71325041 71325042 71325043 71325057 Description COCR 40OD 22ID COCR 41OD 22ID COCR 42OD 22ID COCR 43OD 28ID COCR 44OD 28ID COCR 45OD 28ID COCR 46OD 28ID COCR 47OD 28ID COCR 48OD 28ID COCR 49OD 28ID COCR 50OD 28ID COCR 51OD 28ID 59OD 28ID TNDM SHL/XLPE LNR 39OD26ID LNR 40OD 26ID LNR 41OD 26ID LNR 42OD 26ID LNR 43OD 26ID LNR 57OD 26ID Product No. 71322052 71322053 71322054 71322055 71322057 71324038 71324039 71324040 71324041 71324042 71324043 71324044 71325044 71325045 71325046 71325047 71325048 71325049 71372047 Description COCR 52OD 28ID COCR 53OD 28ID COCR 54OD 28ID COCR 55OD 28ID COCR 57OD 28ID 38OD 22ID 39OD 22ID 40OD 22ID 41OD 22ID 42OD 22ID 43OD 28ID 44OD 28ID 44OD 26ID 45OD 26ID 46OD 26ID 47OD 26ID 48OD 26ID 49OD 26ID TNDM BPLR COCR 43-55 28 SAMP Product No. 71324045 71324046 71324047 71324048 71324049 71324050 71324051 71324052 71324053 71324054 71324055 71324057 71325050 71325051 71325052 71325053 71325054 71325055 Description 45OD 28ID 46OD 28ID 47OD 28ID 48OD 28ID 49OD 28ID 50OD 28ID 51OD 28ID 52OD 28ID 53OD 28ID 54OD 28ID 55OD 28ID 57OD 28ID 50OD 26ID 51OD 26ID 52OD 26ID 53OD 26ID 54OD 26ID 55OD 26ID Trademark of Smith & Nephew 1 / 8

Dear Dr. This letter is to inform you that Smith & Nephew, Inc. has initiated a voluntary field safety corrective action for several lots from the HIP SYSTEM due to a manufacturing error which affected a number of devices in the batches listed below. The affected devices were manufactured with an out of specification retainer groove location. The out of specification condition could potentially result in one of three functional failures: the device will not assemble, the head is too tight or in rare occasions, the device may appear to assemble but later disassociate post operatively. 본서한은아래에리스트된배치의제품에영향을미치는제조문제로인하여 HIP SYSTEM 의 일부 lot 에대해 Smith & Nephew, Inc. 가자발적현장안전시정조치를시작하였음을알리기위함입니다. 해당 제품은고정홈의위치가사양에맞지않게제조되었습니다. 사양에서벗어난상태는잠재적으로세가지기능장애중 하나를일으킬수있습니다 : 제품이결합되지않거나, 헤드가너무타이트하거나, 또는드문경우제품이결합된것처럼 보이지만차후수술후에분리될수있습니다. See Appendix 1 for full list of batch numbers. 배치번호의전체리스트는 Appendix 1 을참조하여주시기바랍니다. This field action has been reported to the relevant competent authorities. 본현장조치는관련규제기관에보고됩니다. Risks to Health 건강에대한위험 Actions to be taken by the user 사용자의조치 If the functional failure is not identified intra-operatively, the implanted assembly could potentially disassociate in the patient postoperatively, requiring a revision surgery. 만약수술중기능장애가확인되지않는다면, 이식된결합이잠재적으로수술후환자내에서 분리될수있으며, 재수술이필요할수있습니다. 1. Locate and quarantine affected unused devices immediately. 즉시사용되지않은제품을격리하여주시기바랍니다. 2. Return quarantined product to your national Smith & Nephew agency/distributor. 격리된제품을 Smith & Nephew 로돌려보내주시기바랍니다. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 다음장의 Return slip 을작성하시어 Smith & Nephew 영업담당자또는 boram.park@smithnephew.com 으로전달하여주시기바랍니다. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 본안전성정보를귀기관내모든관계자에게전달하여주시기바랍니다. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of the action. 본조치의효과를보장하기위하여해당안전조치가종료될때까지본공지사항및결과 조치에대한인식을유지하여주시기바랍니다. 2 / 8

-------------------------------------------------------------------------------------------------------------------------------------- If you have any questions please feel free to contact us under the following contact details: 질문의있으실경우아래의연락처로문의주시기바랍니다. 박보람, Quality Specialist 02) 6001-7582 boram.park@smith-nephew.com 김효경, Product Management Specialist 02) 6001-7566 Hyo-Kyoung.Kim@smith-nephew.com Return Slip 아래의내용을기입하신후 S&N 영업담당자또는 boram.park@smith-nephew.com 으로전달하여주시기바랍니다. HIP SYSTEM 에대한현장안전공지를인지하였음을확인합니다. 본현장안전공지는본기관내에커뮤니케이션되었습니다. * 해당란에표시하여주시기바랍니다 : 본기관은해당제품을보유하고있지않습니다. 아래의제품을반송할예정입니다. ( 아래표에수량을기입하여주시기바랍니다 ) 제품반송수량제품반송수량제품반송수량제품반송수량제품반송수량 71322040 71322041 71322042 71322043 71322044 71322045 71322046 71322047 71322048 71322049 71322050 71322051 71322052 71322053 71322054 71322055 71322057 71324038 71324039 71324040 71324041 71324042 71324043 71324044 71324045 71324046 71324047 71324048 71324049 71324050 71324051 71324052 71324053 71324054 71324055 71324057 71324059 71325039 71325040 71325041 71325042 71325043 71325044 71325045 71325046 71325047 71325048 71325049 71325050 71325051 71325052 71325053 71325054 71325055 71325057 71372047 기관명 : Reference: R-2016-32 성명 : 일자및서명 : 3 / 8

Appendix 1 Affected Batch Numbers Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number 71322040 14AM13511 14AM13511A 71322041 14AM21654 71322042 13LM06353 13MM17938 13MM17940 14AM01852 14AM04660 14AM04662 71322042 13LM06354 13MM17939 71322043 13KM21801 13LM09191 13MM09504 14AM01946 14AM04663 14BM15318 71322043 13LM06356 13LM09204 13MM09507 14AM02029 14AM21664 14BM15318A 71322043 13LM06356A 13MM02843 14AM01855 14AM02046 14BM01137 14BM19345 71322044 13KM21825 13LM09225 13MM09510 14AM02112 14AM04670 14BM08940A 71322044 13KM24083 13LM09236 13MM09517 14AM02118 14AM13546 71322044 13KM24083A 13LM09236A 13MM09517A 14AM02120 14BM01133 71322044 13KM24084 13MM02853 13MM09517B 14AM02120A 14BM01133A 71322044 13LM06357 13MM02857 13MM14125 14AM04667 14BM08938 71322044 13LM06361 13MM02857A 13MM14135 14AM04668 14BM08940 71322045 13KM17382 13KM24087 13MM02862A 13MM17942 14AM04672 14BM08950 71322045 13KM21826 13LM00819 13MM09520 13MM17943 14AM13549 14BM08958 71322045 13KM22753 13LM09243 13MM09520A 13MM17943A 14AM21666 14BM15339 71322045 13KM22755 13LM09247 13MM09523 14AM02117 14AM21669 71322045 13KM24086 13MM02862 13MM17941 14AM02117A 14BM06955 71322046 13KM17387 13LM09274 13LM11684 13MM09524A 14AM04682 14BM15355 71322046 13KM22756 13LM09275 13MM02888A 13MM09526 14AM13552 14BM15358 71322046 13KM22756A 13LM09275A 13MM02892 13MM09527 14AM21677 14BM16787 71322046 13KM24089 13LM09278 13MM02893 13MM09991 14AM21681 14BM19253 71322046 13LM00818 13LM09281 13MM02893A 14AM02121 14BM06952 71322046 13LM00818A 13LM11683 13MM02897 14AM02121A 14BM12173 71322046 13LM09258 13LM11683A 13MM09524 14AM02124 14BM12174 71322047 13LM00809 13LM00817B 13LM11695 13MM02901 14AM21693 14BM16794A 71322047 13LM00809A 13LM09285A 13LM11700 13MM02901B 14BM12175 14BM16795 71322047 13LM00810 13LM09289 13LM14993 13MM09528 14BM12176 14BM16795A 71322047 13LM00816 13LM09289A 13LM15004 13MM09529 14BM16791 71322047 13LM00817A 13LM11689 13MM02900 14AM02127 14BM16794 71322048 13LM01881 13LM01886 13LM11730 13MM02905 14AM13555 14BM08977 71322048 13LM01882 13LM11707 13LM11730A 13MM09994 14AM16949 14BM12177 71322048 13LM01883 13LM11707A 13LM11731 13MM17944 14AM16951 71322048 13LM01883A 13LM11709 13LM14017 13MM17947 14BM08976 71322049 13LM01887 13LM01889 13LM11734 13MM02906 13MM13869A 13MM14122A 71322049 13LM01888 13LM01890 13LM14022 13MM13868 13MM14119 14BM12178 71322049 13LM01888A 13LM11732 13LM14023 13MM13869 13MM14122 14BM12178A 71322050 13LM11735 13LM12855 13LM15017 13MM13870 13MM17994 71322050 13LM12820 13LM12957 13LM15751 13MM13871 13MM17995 71322050 13LM12852 13LM12960 13LM15751A 13MM13871A 14BM01122 71322051 13LM12961 13LM12962A 13LM14032A 13LM14035 13MM13872 14BM16796 71322051 13LM12961A 13LM14025 13LM14033 13LM14037 13MM13873 14BM16796A 71322051 13LM12962 13LM14032 13LM14034A 13LM16186 13MM17997 4 / 8

Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number 71322052 13LM16191 14AM02691 14AM02694 14AM04689 14BM12179A 14BM12182A 71322052 13LM16192 14AM02691A 14AM04683 14AM21695 14BM12179B 14BM12182B 71322052 13LM16193 14AM02692 14AM04687 14AM21695A 14BM12181 71322052 13LM16193A 14AM02693 14AM04688 14BM12179 14BM12182 71322053 13LM16195 14AM02695 14AM02697 14AM16934 14AM21696 14BM12183 71322053 13LM16197 14AM02696 14AM06639 14AM16935 14AM21696A 14BM12184 71322054 13KM22757 13LM16204 14AM02699 14AM02701B 14AM16936 14BM12186 71322054 13KM22758 13LM16204A 14AM02700 14AM02702 14AM16937 71322054 13LM16203 13MM03205 14AM02701 14AM02702A 14AM16937A 71322054 13LM16203A 14AM02698 14AM02701A 14AM02703 14BM12185 71322055 13LM16205 14AM02710A 14AM16940 14BM01110A 14BM12187 71322055 14AM02710 14AM16938 14BM01110 14BM01110B 71322057 14AM16597 14AM16597A 71324038 13LM19426 13LM19431 14BM10263 14BM10264 71324039 13LM16207 14AM08786 14AM08786A 71324040 13LM12963 13LM17120 13MM18005 14BM00728 14BM10265A 14BM16804 71324040 13LM12964 13MM18000 14AM02711 14BM00729 14BM10266 14BM16815 71324040 13LM16210 13MM18001 14AM12034 14BM01149 14BM10266A 71324040 13LM17118 13MM18003 14BM00727 14BM10265 14BM10268 71324041 13LM12870 13LM12880 13MM18006 14AM02713 14AM12043 14BM20733 71324041 13LM12874 13LM17121 14AM02712 14AM02714 14BM00730 71324042 13LM14881 13MM02907 13MM09996 14BM00737 14BM06960 14BM16819A 71324042 13LM14881A 13MM02907A 13MM09998 14BM01141 14BM06961 14BM16820 71324042 13LM14883 13MM02908 13MM09998A 14BM01144 14BM14307 14BM16822 71324042 13LM14883A 13MM02909 14AM12035 14BM03060 14BM14318 14BM16825 71324042 13LM14885 13MM02910 14AM12042 14BM03110 14BM16819 71324043 13LM17122 13LM19387 13MM04114 13MM04124 13MM08123 14AM12038 71324043 13LM17123 13LM19387A 13MM04116 13MM04126 13MM08124 14AM12038A 71324043 13LM17123A 13LM19389 13MM04117 13MM04126A 13MM08124A 14BM00775 71324043 13LM17124 13MM04108 13MM04118 13MM08116 13MM08126 14BM00775A 71324043 13LM17125 13MM04108A 13MM04120 13MM08116A 13MM09999 14BM01146 71324043 13LM17126 13MM04111 13MM04123 13MM08118 13MM10001 71324043 13LM19386 13MM04112 13MM04123A 13MM08121 14AM07555 71324044 13KM22764 13LM17129 13MM04135 14AM24082 14BM04015 14BM06977 71324044 13LM00822 13LM17132 13MM04136 14AM24083 14BM04017 14BM06977A 71324044 13LM00828 13LM17133 13MM04139 14AM24084 14BM04019 14BM08966 71324044 13LM00831 13LM17134 13MM04139A 14AM24084A 14BM04021 14BM08970 71324044 13LM00899 13LM17136 13MM04141 14AM24085 14BM06965 14BM08971 71324044 13LM00900 13LM17157 13MM10009 14AM24086 14BM06966 14BM12189 71324044 13LM06362 13LM17160 14AM15528 14AM24087 14BM06967 14BM12192 71324044 13LM06363 13MM04130 14AM15529 14AM24088 14BM06970 14BM12194 71324044 13LM06364 13MM04130A 14AM21699 14AM24091 14BM06971 14BM12195 71324044 13LM17127 13MM04132 14AM21701 14AM24098 14BM06973 14BM14321 71324044 13LM17128 13MM04132A 14AM21704 14BM04004 14BM06975 14BM14805 71324044 13LM17128A 13MM04134 14AM21707 14BM04014 14BM06975A 14DM11275 5 / 8

Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number 71324045 13KM24095 13LM17165 14AM00474 14AM02715 14AM12041 14BM17706 71324045 13KM24095A 13LM17169 14AM00478 14AM02716 14AM16532 14BM17710 71324045 13KM24097 13LM17169A 14AM00485 14AM02717 14AM24089 14BM17712 71324045 13KM24099 13MM04143 14AM00485A 14AM02717A 14AM24090 14BM17712A 71324045 13LM04114 14AM00467 14AM00490 14AM02718 14BM03989 14BM17713 71324045 13LM06366 14AM00469 14AM00490A 14AM02718A 14BM13827 71324046 13KM24091 13LM15742 13MM13862 14AM02708A 14AM24102A 14BM04026 71324046 13KM24092 13LM15743 13MM13863 14AM02709 14AM24103 14BM14323 71324046 13KM24093 13LM15743A 13MM13864 14AM16514 14AM24103A 14BM14324 71324046 13LM04070 13LM15745 13MM13865 14AM16514A 14AM24108 14BM14324A 71324046 13LM04072 13LM15745A 13MM13866 14AM16515 14AM24109 14BM14327 71324046 13LM04073 13LM15746 13MM13867 14AM16520 14BM00835 14BM19649 71324046 13LM11741 13LM15747 14AM02704 14AM16521 14BM01154 14BM20553 71324046 13LM11741A 13MM13857 14AM02705 14AM16522 14BM01157 71324046 13LM15736 13MM13858 14AM02706 14AM16524 14BM04024 71324046 13LM15741 13MM13859 14AM02707 14AM24101 14BM04024A 71324046 13LM15741A 13MM13860 14AM02708 14AM24102 14BM04025 71324047 13LM00813 13LM14897 13MM14128 14AM00453 14AM16528 14BM14334 71324047 13LM01891 13LM14899 13MM14134 14AM16526 14BM14332 71324047 13LM01892 13MM13677 13MM18008 14AM16526A 14BM14333 71324047 13LM14895 13MM14126 13MM18008A 14AM16526B 14BM14333A 71324048 13LM01893 13LM14908 13MM13695A 14AM00586B 14AM16531 14BM08987 71324048 13LM01894 13LM14909 14AM00527 14AM12010 14BM03036 14BM08988 71324048 13LM01895 13LM14910 14AM00532 14AM12012 14BM03036A 14BM08988A 71324048 13LM14903 13LM14910A 14AM00541 14AM12014 14BM08979 14BM14335 71324048 13LM14905 13MM13470 14AM00562 14AM12014A 14BM08979A 14BM14336 71324048 13LM14905A 13MM13691 14AM00563 14AM12015 14BM08979B 14BM14337 71324048 13LM14906 13MM13692 14AM00567 14AM16529 14BM08980 14BM14338 71324048 13LM14906A 13MM13695 14AM00586 14AM16530 14BM08983 14BM14339 71324049 13MM10141 13MM10147 13MM10150 13MM10160 14BM15222 71324049 13MM10143 13MM10147A 13MM10157 13MM13712 14BM15222A 71324049 13MM10143A 13MM10149 13MM10159 14BM15206 71324050 13KM20614A 13LM07412A 14AM00595 14AM12027A 14BM03022A 14BM15227 71324050 13KM20615 13LM07413A 14AM00599 14AM12029 14BM03022B 14BM15243 71324050 13LM06367 13LM07414 14AM00603 14AM12030 14BM03023 14BM15246 71324050 13LM06370 13LM07414B 14AM06642 14BM03018 14BM03023A 14BM15247 71324050 13LM06371 13LM07415 14AM06643 14BM03021 14BM03025 71324050 13LM06371A 13LM07415A 14AM06644 14BM03021A 14BM03025A 71324050 13LM07412 14AM00593 14AM12027 14BM03022 14BM03026 71324051 13LM07416 13LM07418 14AM02685 14BM15248 14BM15249A 14BM17717 71324051 13LM07417 14AM02684 14AM02685A 14BM15249 14BM15250 6 / 8

Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number 71324052 13LM07419 13LM07425 13MM13701A 14BM03065 14BM11515 14BM19330 71324052 13LM07419B 13MM10273 14AM02686 14BM03066 14BM11526 14CM21388 71324052 13LM07420B 13MM13698 14AM02687 14BM03067 14BM19328 71324052 13LM07420D 13MM13700 14AM02688 14BM03119 14BM19328A 71324052 13LM07422 13MM13700A 14AM02689 14BM11513 14BM19328B 71324052 13LM07424 13MM13701 14AM21904 14BM11514 14BM19329 71324053 13LM04205 13LM04207 13LM04207A 13LM04213 14AM21697 14BM17728 71324054 13LM04201 13LM14911 14AM06637 14BM10269 14BM10272 14BM11528 71324054 13LM04204 13LM14911A 14AM06638 14BM10269A 14BM11527 14BM11530 71324055 13KM22761A 13KM22761C 13LM04199A 13MM13714 14BM15251 71324055 13KM22761B 13KM22762 13MM10153 14BM03126 71324057 13LM04196 14AM12031 14AM12032 14BM19299 71324059 14BM00731 14BM00731A 71325039 13LM14010 13MM15827A 14AM14596 14AM18791 71325039 13MM15827 14AM03055 14AM14596A 14BM18438 71325040 13LM11504 13MM09291 14AM05485 14BM00723 14BM05787 71325040 13LM12921 14AM03739 14AM16892 14BM00725 14BM05787A 71325041 13LM12928 13LM14007A 13MM01327 14AM09899 14AM16953 71325041 13LM12930 13MM01324 14AM05489 14AM15512 14BM05789 71325041 13LM14007 13MM01324A 14AM05492 14AM15514 71325042 13LM05334 13LM05339 13LM12934 14AM05499 14AM15509 14BM05790 71325042 13LM05335 13LM05341 13LM13889 14AM05500 14AM15510 14BM05791 71325042 13LM05337 13LM12933 13LM13891 14AM09891 14AM16954 14BM05792 71325042 13LM05338 13LM12933A 14AM05498 14AM09895 14AM23046 14BM17724 71325043 13LM10125 13LM10151 14AM05505A 14AM15505A 14AM23041 14BM17626 71325043 13LM10126 13LM14912 14AM09900 14AM15506 14AM23044 71325043 13LM10127 14AM03759 14AM09902 14AM15507 14BM05794 71325043 13LM10128 14AM05501 14AM15503 14AM16955 14BM10399 71325043 13LM10129 14AM05502 14AM15503A 14AM16955A 14BM11540 71325043 13LM10130 14AM05505 14AM15504 14AM16957 14BM11540A 71325044 13KM09768 13MM08132 13MM08136A 14AM13561A 14AM16967 14AM23022 71325044 13LM03438 13MM08133 13MM08137 14AM13561B 14AM16968 14BM05795 71325044 13LM03439 13MM08134 14AM13557 14AM16960 14AM16969 14BM10259 71325044 13LM03443 13MM08135 14AM13560 14AM16961 14AM16971 14BM10260 71325044 13LM03444 13MM08135A 14AM13560A 14AM16963 14AM16971A 71325044 13MM08130 13MM08136 14AM13561 14AM16965 14AM23010 71325045 13LM05344 13LM19404A 13MM08035 14AM13564 14AM16972 14BM03983 71325045 13LM19400 13LM19407 14AM09995 14AM16536 14AM16973 14BM03988 71325045 13LM19402 13MM08033 14AM09996 14AM16537 14AM16973A 14BM03988A 71325045 13LM19403 13MM08034 14AM13563 14AM16537A 14AM16974 14BM05796 71325045 13LM19404 13MM08034A 14AM13563A 14AM16539 14BM03981 71325046 13LM05346 13LM19451 13MM09247 14AM16534 14AM23073 14BM11534 71325046 13LM14918 13MM01341 14AM09997 14AM16975 14AM23073A 14BM11536 71325046 13LM14922 13MM09245 14AM09998 14AM16976 14AM23076 71325046 13LM19449 13MM09245A 14AM09999 14AM16976A 14AM23076A 7 / 8

Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number 71325047 13LM13911 14AM03760 14AM12055 14AM13566A 14AM23079 71325047 13LM13912 14AM12045 14AM12062 14AM15499 14BM11537 71325047 13LM13912A 14AM12050 14AM13566 14AM15501 71325048 13LM13988 13MM09279 14AM05514A 14AM16982 14BM11532 71325048 13LM13988A 13MM09279A 14AM16979 14AM23081 14BM11533 71325048 13LM14006 14AM05512 14AM16979A 14AM23084 14BM11533A 71325048 13LM19458 14AM05514 14AM16980 14AM23084A 14CM06925 71325049 13LM05330 13LM05332A 13MM09289 14AM08792 14AM16986 71325049 13LM05330A 13LM13904 13MM09290 14AM16984 14AM23086 71325049 13LM05332 13LM13904A 14AM08791 14AM16985 14AM23089 71325050 13LM03426 13LM03431 13LM13897A 14AM16990 14BM10261 71325050 13LM03426A 13LM05329 13LM13897B 14AM16990A 14BM10262 71325050 13LM03430 13LM08816 14AM03765 14AM16991 14BM10262A 71325050 13LM03430A 13LM13897 14AM12052 14AM17003 71325051 13LM10120 13LM10122 14AM03766 14AM15473 14AM16993A 14AM23129 71325051 13LM10121 13LM17626 14AM05511 14AM16993 14AM23128 14BM03984 71325052 13LM03432 13LM10117 14AM16995 14AM23119 14BM10278 71325052 13LM03434A 14AM05537 14AM17000 14AM23124 71325053 13LM12937 14AM05474A 14AM15517 14BM11539A 14BM11539D 71325053 13MM00436 14AM05476 14AM15517A 14BM11539B 71325053 14AM05474 14AM15516 14BM11539 14BM11539C 71325054 13LM03435 14AM03757 14AM16997 14BM15265 71325055 13LM12939 13MM01365A 14AM15441 14BM10280 71325055 13MM01365 14AM15440 14AM23118 71325057 14BM00722 14BM00722A 71372047 13LM05789 8 / 8