BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE IMPLANTS

    MDR report key: 23461662 · Received November 4, 2025

    Report

    Report Number
    3005180920-2025-01062
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 OCTOBER 2025. GMK-SPHERE 02.12.0024L GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4+L (K140826) LOT. 2236461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOV 2022. EXPIRATION DATE: 06 NOV 2027. 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 02.12.0411FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 11 MM (K140826) LOT. 2241291: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JAN 2023. EXPIRATION DATE: 29 NOV 2027. 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 02.12.T3I4L GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4L (K121416) LOT. 2248752: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27APR 2023. EXPIRATION DATE: 09 APRIL 2028. 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. ROOT CAUSE: THE SURGEON REVISED THE COMPONENTS DUE TO KNEE INSTABILITY, WHICH CAUSED HYPEREXTENSION. 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

    TWO YEARS AND FOUR MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN RELATED TO HYPEREXTENSION, THE CAUSE OF WHICH IS UNKNOWN. THE SURGEON REVISED THE FEMORAL, TIBIAL, AND INSERT COMPONENTS FROM GMK-SPHERE TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720534 GMK SPHERE IMPLANTS GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4+L JWH MEDACTA INTERNATIONAL SA 02.12.0024L 2236461 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention