MPACT 3D METAL

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 17 JULY 2026 LOT: 2314770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2023. EXPIRATION DATE: 11-JUL-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN AND, IN THIS CASE, BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

REVISION SURGERY DUE TO ASCEPTIC LOOSENING OF THE CUP AFTER ABOUT 2 YEARS AND 2 MONTHS FROM PRIMARY. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE COCR BALL HEAD 12/14 D 28 MM SIZE M TO A 28MM BIOLOX OPTION HEAD WITH XL OPTION SLEEVE.