MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

REVISION SURGERY AFTER 2 MONTHS FROM PRIMARY DUE TOINFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND THE HEAD AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 24 JUNE 2026 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT. 2526600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 NOVEMBER 2025. EXPIRATION DATE: 14 OCTOBER 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. 01.32.3648HCT FLAT PE HC LINER D 36/F (K103721) LOT. 2528034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2025. EXPIRATION DATE: 23 NOVEMBER 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.