METHA ¿CAP 12/14 130°/0° SIZE 0

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT NC270T - METHA CAP 12/14 130°/0° SIZE 0. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT WITH PRIMARY OSTEOARTHRITIS UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY IN (B)(6) 2021. THERE WAS A REVISION ARTHROPLASTY DUE TO LOOSENING OF THE FEMORAL COMPONENT IN (B)(6) 2022. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO FURTHER SIMILAR COMPLAINTS WITHIN THIS BATCH. EXPLANATION AND RATIONALE: WITHOUT THE PRODUCT, AN EXACT ROOT CAUSE CANNOT BE DETERMINED AT THIS MOMENT. DUE TO THE STATEMENT OF THE CUSTOMER, THAT THE PATIENT FELL DOWN SEVERAL TIMES, WE ASSUME, THAT THIS MIGHT BE THE REASON FOR THE BREAKAGE OF THE IMPLANT. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.