COLLECT.NO.QAS HIP STEMS MISC./UNKNOWN

Description of Event or Problem

UPDATE: THIS EVENT IS NOW LINKED TO AESCULAP AG REFERENCE NO. (B)(4). THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). 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

ADDITIONAL INFORMATION/CORRECTION: B5 - UPDATED INFORMATION. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCTS WERE NOT RETURNED. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, DEVICE BATCH HISTORY, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCTS WERE FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO OTHER SIMILAR COMPLAINTS WITHIN THIS BATCH. 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. CONCLUSION/PREVENTIVE MEASURES: DUE TO THE LACK OF INFORMATION SURROUNDING THE REPORTED CASE AND WITHOUT THE COMPLAINT SAMPLE BEING AVAILABLE FOR INVESTIGATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED TO US FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THE X-RAYS PROVIDED NO INDICATION OF THE CAUSE OF THE FRACTURE.THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

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). ASSOCIATED MEDWATCH REPORTS: UNKNOWN COREHIP IMPLANT/ 9610612-2024-00132 (AESCULAP AG REFERENCE (B)(4).

Additional Manufacturer Narrative

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