MRHK TIB INS 10MM XS/S S1/S2

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF PATIENT S.W. DISTAL FEMUR GMRS ORIGINALLY PUT IN ON (B)(6) 2025 (ORIGINAL CASE OA 11897482) DUE TO INFECTION AT (B)(6) HOSPITAL ON (B)(6) 2026 TO T2 NAIL CEMENT SPACER (STAGE 1).

Additional Manufacturer Narrative

THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MRS CVD FEM ST W/O BODY 11X127; CAT # 64853811; LOT # 502321E. SMALL HOWMEDICA BONE PLUG 1PK; CAT # 6215-5-001; LOT # CPPACGO3BD. GMRS EXTENSION PIECE 100MM; CAT # 64956100; LOT # U27UD. GMRS DIST FEM COMP SML L 65MM; CAT # 64952010; LOT # RRS6C. GMRS SMALL AXLE; CAT # 64952115; LOT # CTD114541. GMRS SMALL FEMORAL BUSHING; CAT # 64952105; LOT # LNE103. GMRS SMALL FEMORAL BUSHING; CAT # 64952105; LOT # LNL264. GMRS EXTENSION PIECE 60MM; CAT # 64956060; LOT # Y376U. MRH TIBIAL B/PLT KEEL SML 1; CAT # 64813110; LOT # 26A6P. KMAX STEM EXTNR(S,M,L,XL),80MM; CAT # 64768260; LOT # LCP0121. MRHK BUMPER INSERT - NEUTRAL; CAT # 64812130; LOT # LNA443. MRH TIB ROT COMP XS-XL; CAT # 64812100; LOT # 220149. SMALL HOWMEDICA BONE PLUG 1PK; CAT # 6215-5-001; LOT # CPPABMO8 BE. MRHK TIBIAL SLEEVE; CAT # 64812140; LOT # LNC832. SIMPLEX TOBRAMYCIN 1 PK; CAT # 61971001; LOT # TJF061. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAS BEEN SIMILAR EVENT(S) FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.