MPACT ACETABULAR SYSTEM

Description of Event or Problem

AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE 36MM BIOLOX DELTA HEAD L FOR A SAME SIZE HEAD AND REVISED THE FACE CHANG 10° PE HC LINER D 36/E TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 07 JULY 2026 LINER: MPACT 01.32.3644HC10A FACE CHANG 10° PE HC LINER D 36/E (K183582) LOT 2607706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2026. EXPIRATION DATE: 19-MAR-2031. 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. BALL HEADS: MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L (K112115) LOT 2520171: 100 ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2025. EXPIRATION DATE: 27-JUL-2030. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.