MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR IMPLANTS. ON (B)(6) 2026, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS. PRESENTLY ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 15 JULY 2026 BALL HEADS: MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT. 2603307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MARCH-2026. EXPIRATION DATE: 2031-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT. 2528758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2025. EXPIRATION DATE: 2030-11-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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.