UNKNOWN HUMERAL STEM

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY FOR AN UNKNOWN REASON. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-02539, 0001822565-2022-02540. CONCOMITANT MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN GLENOID, LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN HUMERAL HEAD; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY TEN (10) YEARS AND ONE (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT HAD THE FIRST OF A TWO-STEP REVISION PROCEDURE DUE TO INFECTION ON AN UNKNOWN DATE WITH AN ANTIBIOTIC SPACER. THE SECOND PHASE HAS NOT BEEN SCHEDULED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE INFECTION WAS GREATER THAN 90 DAYS POST-OPERATIVELY. THE INITIAL REPORT SHOULD BE VOIDED. 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.