GMK SPHERE TOTAL KNEE SYSTEM

Description of Event or Problem

AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON ALSO EXPRESSED CONCERN OF POTENTIAL OSTEOLYSIS. THE SURGEON REVISED THE TIBIAL INSERT FROM 11 MM TO 13 MM DUE TO FEELING THE KNEE WAS A LITTLE LOOSE WITH THE 11 MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 26 JUNE 2026 GMK-SPHERIKA 02.12.E0211FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2R - 11MM (K202022) LOT 2405541: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2024. EXPIRATION DATE: 27-FEB-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. CLINICAL EVALUATION REVISION SURGERY WAS PERFORMED APPROXIMATELY 16 MONTHS AFTER THE PRIMARY TKA DUE TO REPORTED SIGNS OF INFECTION AND SUSPECTED OSTEOLYSIS. THE AVAILABLE RADIOGRAPHS SHOW FINDINGS CONSISTENT WITH LOOSENING OF THE TIBIAL COMPONENT, ASSOCIATED WITH PERIPROSTHETIC BONE RAREFACTION AT THE TIBIAL PLATEAU ON BOTH THE MEDIAL AND LATERAL SIDES. THESE BONE CHANGES MAY CORRESPOND TO THE OSTEOLYSIS SUSPECTED BY THE SURGEON AND MAY BE COMPATIBLE WITH INFECTION-RELATED BONE LOSS. PERIPROSTHETIC JOINT INFECTION IS A RECOGNIZED POTENTIAL COMPLICATION OF ANY SURGICAL PROCEDURE, INCLUDING TKA. BASED ON THE CURRENTLY AVAILABLE INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE REPORTED EVENT WAS CAUSED BY OR RELATED TO THE IMPLANTED DEVICES. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED; HOWEVER, THE OBSERVED TIBIAL COMPONENT LOOSENING AND PERIPROSTHETIC BONE RAREFACTION MAY BE COMPATIBLE WITH INFECTION-RELATED BONE LOSS. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE IMPLANTED DEVICES CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DID NOT IDENTIFY ANY POTENTIALLY RELATED MANUFACTURING ISSUE.