C/M ELBOW ULNAR

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001822565 - 2018 - 00973. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

IT WAS REPORT THE PATIENT WAS REVISED TO ADDRESS IMPLANT FRACTURE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL:UPDATED CORRECTED DEVICE (B)(4). INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL 62774244 REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. PER THE REVIEW, "FRACTURED LEFT ELBOW ARTHROPLASTY. LUCENCIES ALONG THE HUMERAL AND ULNAR COMPONENTS CONSISTENT WITH LOOSENING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.