OFFSET TIB TRAY 5.0MM ADAPTOR

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. APPROXIMATELY EIGHT YEARS AND TWO MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENTS WITH A PERIPROSTHETIC FRACTURE OF THE FEMORAL CONDYLE. DURING THE REVISION PROCEDURE, THE SURGEON NOTED SIGNIFICANTLY SOFT BONE, SYNOVITIS AND METALLOSIS. THE TIBIAL STEM WAS DIFFICULT TO REMOVE WHICH RESULTED IN A TIBIAL FRACTURE AND UNINTENDED DISASSOCIATION OF THE TIBIAL STEM AND OFFSET ADAPTER. ALL COMPONENTS WERE REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

Additional Manufacturer Narrative

(B)(4). PATIENT WAS BORN IN 1937. CONCOMITANT MEDICAL PRODUCTS: VNGD SSK PSC INTLK FMRL 60 RT: CATALOG#183302, LOT#667480; VNGD DIST FEM AUG 60X5 LL/RM: CATALOG#184122, LOT#346530; VNGD DIST FEM AUG 60X5 RL/LM: CATALOG#184102, LOT#558410; RHK 12X80 CEMENTED STEM: CATALOG#159405, LOT#2114452; BIOMET OFFSET TIBIAL TRAY 63MM: CATALOG#141481, LOT#640750; AGC MOD TIB LOCKING SCREW: CATALOG#153103, LOT#089550; RHK 12X80 CEMENTED STM: CATALOG#159405, LOT#2084361; BIOMET TIB BLOCK 6MM 63: CATALOG#141741, LOT#639830; BIOMET TIB BLOCK 6MM 63: CATALOG#141741, LOT#203910; VNGD SSKPSC TIB BRG S 12X63/67: CATALOG#183822, LOT#486500; COPAL G+C CEMENT 1X40: CATALOG#66017790, LOT#76974354. FOREIGN SOURCE: GERMANY. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01960; 0001825034-2022-01961; 0001825034-2022-01962; 0001825034-2022-01963; 0001825034-2022-01965. DILIGENCE IS IN PROGRESS TO DETERMINE IF THE PRODUCTS WILL BE RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: RIGHT TOTAL KNEE ARTHROPLASTY WITH SUGGESTION OF LOOSENING OF BOTH THE TIBIAL AND FEMORAL COMPONENTS. ASSOCIATED CORTICAL THICKENING WITHIN THE DISTAL FEMORAL DIAPHYSIS AND PROXIMAL TIBIAL DIAPHYSIS SUGGESTS LOOSENING AS WELL. WORSENING OSTEOPENIA. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.