BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 25148964 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00422
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION SURGERY WAS PERFORMED APPROXIMATELY 20 MONTHS AFTER PRIMARY TKA WAS PERFORMED DUE TO A LIMITED RANGE OF MOTION. RADIOGRAPHIC ASSESSMENT SHOWS WELL-POSITIONED AND STABLE COMPONENTS, WITHOUT EVIDENCE OF LOOSENING OR MECHANICAL FAILURE. A POSTERIOR RADIOPACITY IS NOTED, POSSIBLY COMPATIBLE WITH CAPSULAR THICKENING, ALTHOUGH NOT DEFINITIVELY ASSESSABLE. THE CLINICAL SCENARIO IS CONSISTENT WITH POSTOPERATIVE STIFFNESS, A KNOWN MULTIFACTORIAL COMPLICATION AFTER TKA. THE INTRAOPERATIVE IMPROVEMENT FOLLOWING POSTERIOR CAPSULAR RELEASE SUPPORTS A SOFT-TISSUE ORIGIN. THE NEED FOR AN INCREASED DISTAL FEMORAL RESECTION WITH UNCHANGED COMPONENT SIZE SUGGESTS AN INITIAL EXTENSION GAP IMBALANCE RATHER THAN AN ISSUE RELATED TO IMPLANT SIZING OR DESIGN. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF DEVICE MALFUNCTION OR MANUFACTURING DEFECT. THE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY AND IS LIKELY MULTIFACTORIAL. BATCH REVIEW PERFORMED ON 27 APRIL 2026: GMK-SPHERE 02.12.0022L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L (K140826) LOT 2240007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-JAN-2023. EXPIRATION DATE: 2027-DEC-12. 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 02.12.0310FL GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM (K121416) LOT 2001699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2020. EXPIRATION DATE: 2025-MAR-30. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INSUFFICIENT FLEXION AND EXTENSION AFTER TOTAL PROSTHESIS AT 1 YEAR AND 8 MONTHS POST PRIMARY. THE POSTERIOR CAPSULE WAS MANUALLY RELEASED TO INCREASE FLEXION. THE TIBIAL COMPONENT WAS NOT REVISED. FEMORAL COMPONENT REVISED TO ONE OF THE SAME SIZE, SPHERE COMPONENT WITH A 4 MM INCREASED DISTAL CUT. INLAY REVISED WITH THE SAME SIZE AND HEIGHT: STABLE PROTHESIS AND SUFFICIENT FLEXION AND EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376855 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 2+L JWH MEDACTA INTERNATIONAL SA 02.12.0022L 2240007 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1