BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 19936764 · Received August 8, 2024

    Report

    Report Number
    3005180920-2024-00577
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 8, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 JULY 2024. LOT 2112914: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2021. EXPIRATION DATE: 2026-NOV-22. 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 MEDICAL AFFAIRS DEPARTMENT. 1.5 YEARS AFTER PRIMARY TKA THE PATIENT IS FOUND TO BE HYPERSENSITIVE TO NICKEL AND A NEW IMPLANT, WITH LOWER ION RELEASE PROPERTIES, IS USED TO REPLACE THE FORMER ONE. THIS REVISION WAS NOT DICTATED BY A DEFECTIVE DEVICE. ADDITIONAL IMPLANT REVISED BATCH REVIEW PERFORMED ON 16 JULY 2024 ON GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 2210377 LOT 2210377: 24 ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 2027-AUG-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO NICKEL ALLERGY ABOUT 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY. HINGE SYSTEM SENSITIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065502 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2112914 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention