BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22479558 · Received July 11, 2025

    Report

    Report Number
    3005180920-2025-00645
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261884
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 JULY 2025 LOT 2110582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2021. EXPIRATION DATE: 2026-09-20. 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 PERFORMED BY MEDACTA MEDICAL DIRECTOR: ABOUT 2 YEARS AFTER PRIMARY TKA, THE PATELLOFEMORAL ARTICULATION, UNTREATED AT INDEX OPERATION, BECOMES PAINFUL AND NEEDS SURGERY. THE PATELLA IS RESURFACED AND IN THIS OCCASION THE INSERT IS USUALLY REPLACED, EVEN IF NO WORKING PERFECTLY, TO GIVE THE PATIENT A NEW ONE. IN THIS CASE, A THICKER INSERT WAS CHOSEN IN ORDER TO RESTORE STABILITY, AS SOME WAS LOST DUE TO SECONDARY RELAXATION OF LIGAMENTS. ALL DEVICES WERE WORKING PROPERLY AND THE SURGERY WAS DUE TO DISEASE PROGRESSION. 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

    SECONDARY PATELLA BONE RESURFACING DUE TO PERSISTENT PATELLOFEMORAL PAIN APPROXIMATELY 2 YEARS AND 3 MONTHS AFTER INITIAL SURGERY. INLAY REPLACEMENT FROM 13MM TO 17MM TO FURTHER IMPROVE KNEE STABILITY ACCORDING TO SURGEONS NEWER PREFERENCES. ALL OTHER COMPONENTS REMAIN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894127 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE 02.12.E0413FR GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 13MM JWH MEDACTA INTERNATIONAL SA 02.12.E0413FR 2110582 07630971261884

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention