GMK PRIMARY TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 14 JULY 2026 GMK-PRIMARY 02.07.0310SF TIBIAL INSERT STD FIX S.3 / 10 MM (K090988) LOT 171987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2017. EXPIRATION DATE: 26-SEP-2022. 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.

Description of Event or Problem

AT ABOUT 7 YEARS AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE STD. 10MM S3 INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.