BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24603549 · Received March 16, 2026

    Report

    Report Number
    3005180920-2026-00248
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261396
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 MARCH 2026. GMK-SPHERE 02.12. E0213FL GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 13MM (K202022) LOT 2421771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2024. EXPIRATION DATE: 03-SEP-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. GMK-SPHERE 02.07.2802L FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING (K202684) LOT 2342473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2024. EXPIRATION DATE: 19-MAR-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: APPROXIMATELY 4 MONTHS AFTER THE PRIMARY TKA PROCEDURE, THE LINER DISLOCATED FROM THE TIBIAL TRAY. THE AVAILABLE X-RAY IMAGES SHOW A CLEAR MISALIGNMENT BETWEEN THE TIBIA AND THE FEMUR. THE DISLOCATED INSERT IS DIFFICULT TO VISUALIZE DUE TO ITS RADIOLUCENT NATURE; HOWEVER, IT APPEARS TO BE DISPLACED IN A POSTERO-MEDIAL POSITION. THIS ASSUMPTION IS BASED ON A SHADOW VISIBLE IN THE LATERAL VIEW AND ON THE VALGUS ALIGNMENT OF THE KNEE OBSERVED IN THE IMAGES. THE EXACT REASON FOR THE FAILURE CANNOT BE DETERMINED WITH CERTAINTY. NO HISTORY OF TRAUMA HAS BEEN REPORTED. A POTENTIAL ISSUE RELATED TO THE ENGAGEMENT OF THE INSERT WITHIN THE TIBIAL TRAY DURING THE IMPLANTATION PHASE CANNOT BE EXCLUDED; HOWEVER, THE AVAILABLE INFORMATION IS INSUFFICIENT TO DRAW DEFINITIVE CONCLUSIONS. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. BASED ON PREVIOUS SIMILAR EVENTS, IT IS LIKELY THAT THE INSERT WAS NOT CORRECTLY INSERTED IN THE TIBIAL BASEPLATE DURING THE PRIMARY SURGERY BUT THIS CANNOT BE CONFIRMED. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    ABOUT 4 MONTHS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN PRESENTING PAIN DUE TO DISSOCIATION OF THE LINER FROM THE TIBIAL TRAY. THE SURGEON REVISED THE LINER TO THE SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO ANTERIOR KNEE PAIN DUE TO THE PATELLA WAS SUBLUXING OR POSSIBLY DISLOCATING IN EXTENSION. THE SURGEON NOTED THAT THE PATELLA WOULD FLEX LATERALLY, THEN SEEM TO TRACK NORMALLY. THE SURGEON PERFORMED A LATERAL RELEASE OF THE PATELLA TENDON. THE SURGEON THEN PERFORMED A WASHOUT AND POLY SWAP PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. EVENT RELATED ASLO TO MDR 2025-01134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666660 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 2L - 13MM JWH MEDACTA INTERNATIONAL SA 02.12.E0213FL 2421771 07630971261396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention