GMK HINGE TOTAL KNEE SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 19 JUNE 2026 LOT 143006: (B)(54)ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2014. EXPIRATION DATE: 31-MAY-2019. 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. LOT 143004: (B)(4) MANUFACTURED AND RELEASED ON 11-JUL-2014. EXPIRATION DATE: 31-MAY-2019. 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. R&D ANALYSIS BASED ON THE PROVIDED PICTURES ACCORDING TO THE AVAILABLE PHOTOGRAPHIC DOCUMENTATION, SCRATCHES APPEAR TO BE VISIBLE ON THE DISTAL REGIONS OF THE FEMORAL CONDYLES AND ON THE TIBIAL INSERT. BASED SOLELY ON VISUAL ASSESSMENT, NO FURTHER EVALUATION CAN BE PERFORMED. NO PHOTOGRAPHS OF THE EXPLANTED PATELLAR COMPONENT WERE PROVIDED. ACCORDING TO THE OPERATING SURGEON, THE GEOMETRY OF THE PREVIOUSLY IMPLANTED COMPETITOR PATELLAR COMPONENT MAY NOT HAVE BEEN OPTIMAL, POTENTIALLY AFFECTING PATELLAR TRACKING AND CONTRIBUTING TO POLYETHYLENE PARTICLE GENERATION, SYNOVIAL TISSUE PROLIFERATION, AND THE OBSERVED INFLAMMATORY RESPONSE. HOWEVER, BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO CONCLUSIVE EVIDENCE HAS BEEN IDENTIFIED TO DETERMINE A DEFINITIVE ROOT CAUSE. ROOT CAUSE:THE OBSERVED FINDINGS MAY HAVE BEEN INFLUENCED BY CASE-SPECIFIC FACTORS, INCLUDING THE GEOMETRY OF THE PREVIOUSLY IMPLANTED COMPETITOR PATELLAR COMPONENT, WHICH MAY HAVE AFFECTED PATELLAR TRACKING AND CONTRIBUTED TO POLYETHYLENE PARTICLE GENERATION, SYNOVIAL TISSUE FORMATION, AND INFLAMMATION. HOWEVER, NO CONCLUSIVE EVIDENCE IS AVAILABLE TO CONFIRM THIS HYPOTHESIS. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

THE PATIENT UNDERWENT MULTIPLE RIGHT KNEE REVISION SURGERIES FOLLOWING A PREVIOUS UNICOMPARTMENTAL KNEE REPLACEMENT AND SUBSEQUENT CONVERSION TO A COMPETITOR TOTAL KNEE REPLACEMENT. IN 2015, THE PATIENT WAS REVISED TO A MEDACTA HINGE KNEE DUE TO INSTABILITY, AND ON (B)(6) 2017, THE HINGE LINER WAS EXCHANGED FOR A THICKER 26 MM INSERT (FROM 20MM TO 26MM). NO OTHER INFORMATION IS AVAILABLE REGARDING THIS REVISION SURGERY. THE PATIENT LATER REPORTED PERSISTENT RIGHT KNEE PAIN, WITH PATHOLOGY FINDINGS SHOWING SIGNS OF INFLAMMATION. DURING THE LATEST REVISION SURGERY, PERFORMED ABOUT 9 YEARS AND 3 MONTHS AFTER THE PREVIOUS REVISION SURGERY, EXCESSIVE SYNOVIAL TISSUE WAS REMOVED, THE HINGE INSERT WAS REPLACED WITH A NEW INSERT OF THE SAME SIZE, AND THE COMPETITOR PATELLAR COMPONENT WAS REPLACED WITH A MEDACTA PATELLA. THE OPERATING SURGEON CONSIDERED THAT THE COMPETITOR PATELLA MAY NOT HAVE HAD AN OPTIMAL SHAPE, POTENTIALLY AFFECTING PATELLAR TRACKING AND CONTRIBUTING TO POLYETHYLENE PARTICLE GENERATION, SYNOVIAL TISSUE FORMATION, AND INFLAMMATION. SLIGHT WEAR OF THE PATELLAR INSERT AND SCRATCHES ON THE FEMORAL COMPONENT AND ON THE TIBIAL INSERT WERE ALSO OBSERVED. THE WOUND WAS CLOSED WITHOUT FURTHER CONCERNS.