DM CONVERTER ¿ TIN COATED

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER 26 DAYS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE DM CONVERTER AND DM LINER TO A SAME TYPE CONVERTER AND SAME SIZE LINER.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 10 JULY 2026 MPACT DM 01.32.4452CF DM CONVERTER G/DMF - TIN COATED LOT. (K211891), 2429700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2025. EXPIRATION DATE: 19-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. MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER D 28/DMF (K092265), LOT. 2534750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2026. EXPIRATION DATE: 03-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. 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.