BIOLOX PROSTHESIS HEAD 12/14 32MM M

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NK561 - BIOLOX PROSTHESIS HEAD 12/14 32MM M. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS POSTOPERATIVE "NOISE" FROM THE AFFECTED AREA. THE TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED APPROXIMATELY 14 YEARS AGO. THE REPLACEMENT SURGERY WAS PLANNED FOR LINER AND HEAD; THE PROCEDURE WAS POSTPONED IN ORDER TO PRIORITIZE TREATMENT FOR ANOTHER UNSPECIFIED DISEASE/CONDITION. 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, BUT HAD BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO.(B)(4). OTHER LEADING MATERIAL - NOT SOLD IN US: NH102/ SC/MSC CERAMICS INSERT 32MM 48/50 SYM. (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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - UPDATED DESCRIPTION.

Description of Event or Problem

UPDATE: REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2025. BOTH THE LINER AND HEAD WERE REPLACED, BUT STEM AND CUP WERE PRESERVED. NO DAMAGES OR WEAR OBSERVED ON ANY IMPLANTS. THE PATIENT HAD NO PROBLEMS WITH DAILY ACTIVITIES AND HAD NO FALLS OR OTHER EVENTS. OTHER LEADING MATERIAL - NOT SOLD IN US: NH102/ SC/MSC CERAMICS INSERT 32MM 48/50 SYM. (AESCULAP AG REFERENCE NO. (B)(4)).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. BASED ON THE NUMBERS PROVIDED, THE COMPONENTS AT ISSUE COULD BE IDENTIFIED AS CERAMTEC COMPONENTS. PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT AND ON THE FEMORAL HEAD CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. 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 FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. 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

OTHER LEADING MATERIAL - NOT SOLD IN US: NH102/ SC/MSC CERAMICS INSERT 32MM 48/50 SYM. (AESCULAP AG REFERENCE NO. (B)(4)).