BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 17388872 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00599
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JULY 2023: LOT 2111937: 150 ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 129 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALAUTION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: A SECOND REVISION SURGERY WAS PERFORMED 8 MONTHS AFTER A FIRST REVISION AIMED AT RESURFACING THE PATELLA, IN THE CONTEXT OF A GMK SPHERE. AFTER THE FIRST REVISION SURGERY, THE PATIENT SOLVED THE PREVIOUS ANTERIOR KNEE PAIN, BUT COMPLAINED OF MEDIAL KNEE PAIN. FROM THE AVAILABLE X RAY IMAGES, WE CAN ASSESS A TIBIAL TRAY SLIGHTLY MEDIALIZED. THE CAUSE OF THE MEDIAL PAIN IS DIFFICULT TO DETERMINE, BUT THE TIBIAL TRAY OVER THE EDGE MAY HAVE IMPINGED THE MEDIAL SOFT TISSUES DEVELOPING THE SYMPTOMATOLOGY. THE REVISION SURGERY PROVIDED THE CHANGE OF THE TIBIAL TRAY AND THE INSERT. WE HAVE NO REASON TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE PATIENT HAD A PRIMARY KNEE SURGERY. ON (B)(6) 2022, THE PATIENT REPORTED ANTERIOR KNEE PAIN. THE SURGEON RESURFACED THE NATURAL PATIENT'S PATELLA. PRESENTLY ON (B)(6) 2023, REVISION SURGERY DUE TO CEMENTED TIBIAL TRAY OVERHANGING. PAIN DESCRIBED BY THE PATIENT. NO INFECTION, NO LOOSENING OF THE IMPLANTS. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864536 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2111937 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention