COLLECT.NO.QAS HIP STEMS MISC./UNKNOWN

Additional Manufacturer Narrative

CORRECTION: B5 - UPDATED INFORMATION - THIS COMPLAINT IS CONSIDERED TO BE A DUPLICATE.

Description of Event or Problem

UPDATE: THIS COMPLAINT IS NOW CONSIDERED TO BE A DUPLICATE. (THE ACTUAL COMPLAINT FILES ARE LISTED BELOW). ASSOCIATED MEDWATCH REPORTS: UNKNOWN COREHIP IMPLANT/ 9610612-2024-00131 (AESCULAP AG REFERENCE NO.(B)(4)). UNKNOWN COREHIP IMPLANT/ 9610612-2024-00132 (AESCULAP AG REFERENCE NO.(B)(4)) - DUPLICATE REPORT. UNKNOWN COREHIP IMPLANT/ 9610612-2024-00133 (AESCULAP AG REFERENCE NO.(B)(4)).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNKNOWN COREHIP IMPLANT. ACCORDING TO THE COMPLAINT DESCRIPTION, POSTOPERATIVELY AFTER THE BILATERAL TOTAL HIP ARTHOPLASTIES (THA), FEMORAL FRACTURES WERE NOTED. CEMENT STEMS WERE THEN IMPLANTED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4) ((B)(4) ). ASSOCIATED MEDWATCH REPORTS: UNKNOWN COREHIP IMPLANT/ 9610612-2024-00131 (AESCULAP AG REFERENCE NO.(B)(4) ).