BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 24603545 · Received March 16, 2026

    Report

    Report Number
    3005180920-2026-00208
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    November 20, 2020
    Report Date
    March 16, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826573
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 FEB 2026. LOT 1901306: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2019. EXPIRATION DATE: 2024-MAY-06. 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: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. 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

    PRIMARY SURGERY PERFORMED ON THE (B)(6) 2020. IMPLANTATION OF GMK-SPHERE COMPONENTS WITHOUT PATELLA RESURFACING. REVISION SURGERY PERFORMED ON THE (B)(6) 2020 DUE TO ANTERIOR PAIN DESCRIBED BY THE PATIENT AND LAXITY OF THE KNEE. IMPLANTATION OF A RESURFACING PATELLA SIZE 2. 12MMLINER REVISED WITHA 14MM LINER. EVENT ALSO RELATED TO MDR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666664 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL INSERT - FLEX S4L - 12 MM JWH MEDACTA INTERNATIONAL SA 02.12.0412FL 1901306 07630030826573

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention