MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

REVISION SURGERY AFTER 1 MONTH FROM THE MEDACTA PRIMARY DUE TO INFECTION.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 09 JULY 2026 BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT. 2513372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2025. EXPIRATION DATE: 13-MAY-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. LINER: MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER D 28/DME (K092265) LOT. 2521259: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2025. EXPIRATION DATE: 15-SEP-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. LINER: MPACT 01.32.4248CF DM CONVERTER F/DME - TIN COATED (K211891) LOT. 2430722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2025. EXPIRATION DATE: 16-MAR-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.