COLLECT.NO.QAS ACETAB.CUPS MISC./UNKNOWN

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, AFTER THE TOTAL HIP ARTHOPLASTY OPERATION, A FEMORAL BREAKAGE WAS NOTICED; HENCE, A REVISION SURGERY WAS CARRIED OUT. 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)..

Additional Manufacturer Narrative

INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS ONE SIMILAR COMPLAINT AGAINST THE LOT NUMBER 52691113 AND 52666148. (THE DATE OF INITIAL SURGERY WAS USED TO TRACE THE PROBABLE BATCH NUMBER(S)) 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: ON THE BASIS OF THE INVESTIGATION AND THE CURRENT INFORMATION, A DEFINITIVE ROOT CAUSE FOR THE MENTIONED FAILURE COULD NOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE ARE NO HINTS REGARDING A MATERIAL, MANUFACTURING, OR DESIGN-RELATED FAILURE./ PROBLEM. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: A CEMENTED STEM WAS IMPLANTED DURING THE REVISION SURGERY.