GMK PRIMARY TOTAL KNEE SYSTEM

Description of Event or Problem

THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2025. APPROXIMATELY ONE YEAR AFTER SURGERY, THE PATIENT EXPERIENCED PAIN IN THE JOINT, AND X-RAYS CONFIRMED TIBIAL LOOSENING. A REVISION SURGERY IS SCHEDULED FOR (B)(6), 2026.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JULY 2026 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT. 2430222:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MARCH 2025. EXPIRATION DATE: 17 FEBRUARY 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. CLINICAL EVALUATION THE AVAILABLE INFORMATION SUPPORTS A DIAGNOSIS OF TIBIAL TRAY LOOSENING APPROXIMATELY ONE YEAR AFTER PRIMARY CEMENTED TKA. THE SINGLE AVAILABLE RADIOGRAPHIC IMAGE CONFIRMS TIBIAL TRAY MOBILIZATION WITH RADIOLUCENT LINES, PARTICULARLY BENEATH THE TIBIAL PLATEAU. ASEPTIC LOOSENING OF THE TIBIAL COMPONENT IS A KNOWN POSSIBLE ADVERSE EVENT AFTER PRIMARY TKA, AND ITS ETIOLOGY IS OFTEN MULTIFACTORIAL OR UNCLEAR. EVEN IN THIS CASE, THE ROOT CAUSE REMAINS UNDETERMINED. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE EVIDENCE OF DEVICE MALFUNCTION, MANUFACTURING DEFECT, OR DESIGN DEFICIENCY HAS BEEN IDENTIFIED. ROOT CAUSE:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.