BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23234088 · Received October 7, 2025

    Report

    Report Number
    3005180920-2025-00983
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 24 SEPTEMBER 2025: GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX SIYE 6/10 MM L (K121416) LOT 2201091: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2022. EXPIRATION DATE: 2027-03-08. 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-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L (K090988) LOT 2118080: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APRIL-2022. EXPIRATION DATE: 2027-03-28. 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-SPHERE 02.12.0007L FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L (K121416) LOT 2207169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2022. EXPIRATION DATE: 2027-06-09. 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. VISUAL INSPECTION PERFORMED BY MEDACTA KNEE R&D MANAGER: A REVISION OF A GMK SPHERE IMPLANT WAS REQUIRED DUE TO PAIN AND INSTABILITY, OCCURRING APPROXIMATELY 2.5 YEARS AFTER THE PRIMARY SURGERY. PRE-REVISION X-RAY REPORTEDLY SHOWED LATERAL DISLOCATION OF THE TIBIAL INSERT, ALTHOUGH THE IMAGES WERE NOT AVAILABLE FOR REVIEW. INTRAOPERATIVELY, THE TIBIAL INSERT WAS FOUND DISENGAGED FROM THE BASEPLATE. THE EXPLANTED INSERT, SUBMITTED FOR INVESTIGATION, PRESENTED DENTS AND SCRATCHES ON THE POSTERIOR BOTTOM SURFACE. THE POSTERIOR FEATURES OF THE SNAPPING MECHANISM APPEARED DAMAGED AND DEFORMED, WITH INCISIONS CORRESPONDING TO THE NEGATIVE SHAPE OF THE OUTER CONTOUR OF THE BASEPLATE. THESE SIGNS ARE CONSISTENT WITH THE CONDITION OF AN INSERT THAT, ONCE DISENGAGED AND RESTING ON THE BASEPLATE, WAS SUBJECTED TO COMPRESSIVE FORCES FROM BODY LOAD. IT IS SUSPECTED THAT THE INSERT MAY NOT HAVE BEEN FULLY ENGAGED INTO THE BASEPLATE DURING THE PRIMARY SURGERY; HOWEVER, THIS CANNOT BE CONCLUSIVELY CONFIRMED. NO EVIDENCE OF DEVICE MALFUNCTION WAS IDENTIFIED THROUGH VISUAL INSPECTION. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY SCENARIO IS THAT INCOMPLETE ENGAGEMENT OF THE TIBIAL INSERT AT THE TIME OF IMPLANTATION LED TO DISENGAGEMENT AND SUBSEQUENT DAMAGE. THERE ARE NO INDICATIONS THAT THE EVENT WAS CAUSED BY A FAULTY DEVICE. DURING REVISION SURGERY, THE FEMORAL COMPONENT WAS ALSO REPLACED. THE REASON FOR REVISING THE FEMORAL COMPONENT WAS THAT THE HIP-KNEE-ANKLE ANGLE HAD BEEN SLIGHTLY VALGUS SINCE THE PRIMARY SURGERY, AND THE SURGEON DECIDED TO CORRECT THE ALIGNMENT. VISUAL ANALYSIS OF THE RETRIEVED FEMORAL COMPONENT SHOWED MILD SCRATCHES ON THE ARTICULAR SURFACE, CONSISTENT WITH A COMPROMISED SITUATION DUE TO TIBIAL INSERT DISLOCATION. BONE TISSUE IS PRESENT ON THE INTERNAL SHAPE OF THE FEMORAL COMPONENT, SHOWING A GOOD CEMENT FIXATION OF THE DEVICE. THE FEMORAL REVISION REQUIRED DOWNSIZING OF THE COMPONENT AND THE USE OF A THICKER TIBIAL INSERT. ALSO IN THIS CASE, THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A DEVICE FAULT. ALTHOUGH IT IS NOT POSSIBLE TO CONFIRM A CERTAIN ROOT CAUSE, IT IS LIKELY THAT THE UNIQUE CHALLENGES OF THE SURGICAL APPLICATION RESULTED IN AN IMPEDIMENT TO FULLY SECURING THE INSERT WITH THE POSSIBILITY THAT THE INSERT WAS NOT FULLY CLIPPED INTO THE INTENDED POSITION. THE DEGREE OF VALGUS OBSERVED POSTOPERATIVELY IS MOST LIKELY RELATED TO THE ISOLATED AND UNIQUE APPLICATION-SPECIFIC CONDITIONS. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY DUE DISSOCIATION OF THE TIBIAL INSERT FIXED 10MM (STANDARD PE) ABOUT 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE REASON FOR REVISING THE FEMORAL COMPONENT WAS THAT THE HIP-KNEE-ANKLE ANGLE HAD BEEN SLIGHTLY VALGUS SINCE THE PRIMARY SURGERY. DURING REVISION A THICKER INSERT WAS IMPLANTED AND THE FEMORAL COMPONENT WAS CHANGED FROM SIZE 7 TO SIZE 6 BECAUSE SOME POSTERIOR BONE WAS LOST DURING THE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746711 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L JWH MEDACTA INTERNATIONAL SA 02.12.0610FL 2201091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention