DOUBLE MOBILITY LINER

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER 12 DAYS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE DM LINER AND THE HEAD.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 07 JULY 2026 MPACT DM 01.26.2848MHC DOUBLE MOBILITY HC LINER D 28/DMD (K092265) LOT. 2601003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAR-2026. EXPIRATION DATE: 15-FEB-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. MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT. 2606576: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2026. EXPIRATION DATE: 15-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. 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.