BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 24494905 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00189
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MARCH 2026. GMK-SPHERE 02.07.0036RP RESURFACING PATELLA SIZE 4 (K113571) LOT 2202670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2022. EXPIRATION DATE: 05-MAY-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 02.12.0511FR GMK-SPHERE TIBIAL INSERT - FLEX S5R - 11 MM (K140826) LOT 2009037: (B)(4) ITEMS MANUFACTURED AND RELEASED 26-NOV-2020. EXPIRATION DATE: 28-OCT-2025. 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 LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO OVER ROTATION OF THE KNEE. THE SURGEON OBSERVED THAT THE PATELLA IMPLANT HAD COME FREEAND PERFORMED A REVISION OF THE PATELLA, UPSIZING THE INSERT TO IMPROVE STABILITY AND ADDRESS THE EXCESSIVE ROTATION EXPERIENCED BY THE PATIENT.. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450402 GMK PRIMARY TOTAL KNEE SYSTEM RESURFACING PATELLA SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 2202670 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention