GMK HINGE TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 3 MONTHS FROM PRIMARY, THE PATIENT HAD SIGNS OF HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED THE PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025 ALL DEVICES HAVE BEEN REVISED FOR INFECTION AND A SPACER WAS IMPLANTED. ON (B)(6) 2025 THE SPACER WAS REMOVED AND THE FINAL DEVICES WERE IMPLANTED. ON (B)(6) 2026, THE PATIENT HAD SIGNS OF HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL PERMANENT GMK-HINGE IMPLANTS AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEWS PERFORMED ON 7 JULY 2026: GMK-HINGE 02.09.0414H GMK-HINGE TIBIAL INSERT - SIZE4 - 14 MM (K130299) LOT 2219279: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2022. EXPIRATION DATE: 31-AUG-2027. 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. GMK-HINGE 02.09.2704L GMK-HINGE FEMORAL COMPONENT SIZE4 L - TINBN COATED (K210010) LOT 2418342: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2024. EXPIRATION DATE: 06-OCT-2029. 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. GMK-HINGE 02.09.4804L GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 4L (K210010) LOT 2400933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2025. EXPIRATION DATE: 05-FEB-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.