ARCOS CON SZ B HI 60MM

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

Description of Event or Problem

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

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL DEVICES: PART # UNKNOWN / UNKNOWN STEM/ LOT # UNKNOWN; PART #UNKNOWN / UNKNOWN HEAD/ LOT # UNKNOWN; PART #UNKNOWN / UNKNOWN LINER/ LOT # UNKNOWN; PART #UNKNOWN / UNKNOWN SCREW/ LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -00605.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT WAS REVISED ONE-YEAR POST IMPLANTATION DUE TO A FALL CAUSING DISLOCATION. DURING THE REVISION IT WAS DISCOVERED THE TAPER JUNCTION BETWEEN THE AROCS CONE BODY AND STEM WAS NOT ENGAGED. HOWEVER, THE SET SCREW WAS FOUND TO BE IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.