GMK PRIMARY TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JULY 2026 GMK-PRIMARY 02.07.1202R TIBIAL TRAY FIX CEMENTED S.2R (K090988) LOT. 2518198: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2025. EXPIRATION DATE: 2030-11-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.2202R FEMUR PS CEMENTED SIZE 2 R (K090988) LOT. 2318096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2023. EXPIRATION DATE: 2028-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0210PSF TIBIAL INSERT PS FIXED SIZE 2/10MM (K090988) LOT. 2528257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2026. EXPIRATION DATE: 2030-12-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: AN EARLY POSTOPERATIVE PERIPROSTHETIC JOINT INFECTION OCCURRED APPROXIMATELY FIVE AND A HALF WEEKS AFTER PRIMARY RIGHT CEMENTED TOTAL KNEE ARTHROPLASTY AND REQUIRED REMOVAL OF ALL COMPONENTS WITH PLACEMENT OF AN ANTIBIOTIC SPACER. A SPECIFIC POTENTIAL CONTAMINATION EVENT OCCURRED DURING THE PRIMARY PROCEDURE WHEN A MEDACTA REPRESENTATIVE LOST CONSCIOUSNESS AND FELL ONTO THE SURGICAL DRAPES CLOSE TO THE OPEN SURGICAL FIELD. THIS EVENT PROVIDES A MEDICALLY PLAUSIBLE ROUTE OF CONTAMINATION AND MAY HAVE CONTRIBUTED TO THE SUBSEQUENT INFECTION. HOWEVER, THE AVAILABLE EVIDENCE DOES NOT CONFIRM A DIRECT CAUSAL RELATIONSHIP, BECAUSE THE STERILE-FIELD BREACH IS NOT FULLY CHARACTERIZED AND MICROBIOLOGICAL, SURGICAL, AND PATIENT-RISK INFORMATION IS UNAVAILABLE. NO EVIDENCE CURRENTLY SUPPORTS AN INTRINSIC MALFUNCTION, MANUFACTURING DEFECT, OR MECHANICAL FAILURE OF THE IMPLANTED GMK PRIMARY COMPONENTS. THE ROOT CAUSE OF THE INFECTION CANNOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION AT HAND. 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

REVISION SURGERY WAS PERFORMED 1 MONTH AND HALF AFTER THE PRIMARY DUE TO INFECTION. THE SURGEON REMOVED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACER. DURING THE PRIMARY SURGICAL PROCEDURE THE MEDACTA REPRESENTATIVE EXPERIENCED A MEDICAL EVENT, LOST CONSCIOUSNESS, AND FELL INTO THE OPEN SURGICAL FIELD ON THE SURGICAL DRAPS BEFORE COLLAPSING ONTO THE FLOOR. FOLLOWING THE EVENT, THE SURGEON INITIATED THE DISINFECTION PROTOCOL DUE TO THE POTENTIAL CONTAMINATION RISK OF THE SURGICAL SITE.