BMT SPLINED KNEE STM V2 16X80 80

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. CLINICAL NOTES FOUND THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FEMORAL LOOSENING; EVIDENCE OF SCALLOPING WHICH RESULTED IN PAIN AND DIFFICULTY AMBULATING. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 ADDITIONAL INFORMATION REPORTED.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK 360 LEFT FEMUR CATALOG 185288 LOT 2823216, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 115580, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 354980, BIOMET 360 OFFSET ADAPTER CATALOG 185211 LOT 497570, BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200, BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800, BIOMET 360 OFFSET ADAPTER CATALOG 185211 LOT 497570, VANGUARD SSK TIBIAL BEARING CATALOG 185104 LOT 985950, UNKNOWN COBALT BONE CEMENT. CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION ARTHROPLASTY APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO PAIN AND LOOSENING OF THE FEMORAL COMPONENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.