NEXEL ELBOW

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS IN THE D10 NARRATIVE BELOW. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - (B)(6) (UNKNOWN) - UNKNOWN LONG ULNA (UNKNOWN) - UNKNOWN ARTICULATION KIT (UNKNOWN) G2: FOREIGN - THE EVENT OCCURRED IN AUSTRALIA. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND RIGHT TOTAL ELBOW REVISION DUE TO INFECTION, LOOSENING, AND LYSIS. THE PATIENT HAD PREVIOUSLY UNDERGONE AN INITIAL RIGHT TOTAL ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT WAS SUBSEQUENTLY REVISED FOR THE FIRST TIME. DURING THE FIRST REVISION, EXTENSIVE METALLOSIS WAS NOTED, ASSOCIATED WITH A FAILED CENTRAL PIN AND BEARING WEAR. THE HUMERAL AND ULNA IMPLANTS WERE WELL FIXED AT THAT TIME. ALL IMPLANTS WERE REVISED WITHOUT COMPLICATIONS. APPROXIMATELY SIX YEARS AND NINE MONTHS AFTER THE FIRST REVISION, THE PATIENT UNDERWENT A SECOND REVISION DUE TO INFECTION, LOOSENING, AND LYSIS. DELAMINATION OF THE HUMERAL COMPONENT WAS REPORTED. THE PATIENT UNDERWENT REVISION SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.