BIOMET FND TIB TY POL COCR PC

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR POR FMRL-LT 65 CATALOG # 183068 LOT # 187910, BMET REGENX PRI TIB TRAY 67MM CATALOG # 141272 LOT # 303980, MODULAR SPLINED STEM 40MM CATALOG # 141369 LOT # 473940, VNGD ANT STBLZD BRG 10X67 CATALOG # 189040 LOT # 797610. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FRACTURED PATELLA PROSTHESIS AND CLICKING NOISE. THE PATELLA WAS REMOVED AND REPLACED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI #: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS THAT THE PATELLA PEGS HAVE SHEARED OFF AND THE ARTICULATING SURFACE HAS METAL SHAVINGS EMBEDDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE WAS DETERMINED TO BE A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. THE EVENT IS BEING REVIEWED THROUGH THE CAPA PROCESS. X-RAY REVIEW INDICATES THERE IS SHEARING OF THE PATELLAR PEG HARDWARE COMPONENT. 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.