BIOMET PRIMARY TIBIAL PLATE WITH LOCKING BAR 83MM INTERLOK

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS- BIOMET MODULAR FINNED STEM WITH SCREW 80 MM ITEM #:141320, LOT #: 683040; OPTIPAC BONE CEMENT CATALOG UNKNOWN LOT UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL BASEPLATE, DURING WHICH IT WAS NOTICED THAT THE CONNECTION OF THE MODULAR TIBIAL PLATE AND STEM WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MODULAR FINNED STEM WITH SCREW 80 MM ITEM #:141320 LOT #: 683040. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS NOT INDICATED IF PRODUCT IS TO BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-02095.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO A FRACTURE OF THE IMPLANTED COMPONENT CONNECTION OF THE MODULAR TIBIAL PLATE AND STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF DHR FOR THE PARTS DETERMINED THAT THERE WERE NO ANOMALIES AND DEVIATIONS FOR THESE PARTS AND LOT COMBINATION. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. X-RAY EVALUATION REPORT FROM MMI STATE THAT THE IMAGES TAKEN IN THE INITIAL POSTOP PHASE AND AT 8 MONTHS SHOW INTACT HARDWARE WHICH IS NORMALLY ALIGNED BESIDES THE TIBIAL STEM/CONE, WHICH IS POSITIONED ECCENTRICALLY LATERAL WITHIN THE TIBIA (THE TIP OF THE STEM APPROXIMATES THE ENDOSTEUM). AT 31 MONTHS, A NEWLY APPARENT NONDISPLACED FRACTURE HAS APPEARED WITHIN THE CONE CONNECTOR WITHIN THE TIBIA. IT IS NOT CERTAIN, BUT IT IS POSSIBLE THAT THE POSITIONING OF THE CONE WITHIN THE TIBIA COULD HAVE CONTRIBUTED TO STRESSES ON THE SYSTEM THAT LED TO THE FRACTURE. THE REMAINDER OF THE HARDWARE IS INTACT. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.