BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20557968 · Received October 29, 2024

    Report

    Report Number
    3005180920-2024-00898
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815768
    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 11-OCT-2024. LOT: 2112779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2021. EXPIRATION DATE: 2026-11-28. 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 CLINICAL AFFAIRS DEPARTMENT ABOUT 2.5 YEARS AFTER REVISION OF PATELLA RESURFACING CONSEQUENT TO A TRAUMATIC EVENT, THE PATELLA IS FOUND PAINFUL AGAIN AND A NEW REVISION IS UNDERTAKEN. THE TIBIOFEMORAL IMPLANTS ARE STILL WORKING SATISFACTORILY, REPLACEMENT OF THE TIBIAL INSERT IS CARRIED OUT AS STANDARD PRECAUTIONARY MEASURE. THE RESURFACING PATELLA IS EXCHANGED AGAIN BUT THE MOST IMPORTANT ACTION TAKEN BY THE SURGEON IS THE UPLIFTING OF THE ANTERIOR TIBIAL TUBEROSITY, WHICH IN HIS OPINION COULD SOLVE THE PROBLEM. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS REVISION.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) APRIL 2015. GMK-SPHERE FEMUR, TIBIA AND INSERT IMPLANTED. ON (B)(6) 2016, THE PATIENT HAS BEEN REVISED (COMPLEMENTARY SURGERY) AND PATELLA IMPLANT SIZE 3 HAS BEEN IMPLANTED. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN AND UNDERGONE A REVISION SURGERY BECAUSE OF A FALLING ON (B)(6) 2021 WITH SUBSEQUENT LOOSENING OF THE PATELLA IMPLANT. NO LOOSENING OF THE OTHER COMPONENTS OR INFECTION. IMPLANTATION OF A NEW PATELLA IMPLANT SIZE 3. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND IT WAS SUSPECTED LOOSENING OF PATELLA IMPLANT. RESURFACING OF PATELLA SIZE 3 AND IMPLANTATION OF A NEW SIZE 3. NO LOOSENING OF THE COMPONENTS DETECTED. CHANGING OF THE TIBIAL INSERT WAS DONE AS PREVENTIVE MEASURE. MOREOVER, THE SURGEON DECIDED TO RAISE THE ANTERIOR TIBIAL TUBEROSITY BECAUSE THE PATELLA WAS VERY LOW AND THIS COULD EXPLAIN THE PAIN, ACCORDING TO THE SURGEON OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923776 GMK PRIMARY TOTAL KNEE SYSTEM KNEE PATELLA RESURFACING IMPLANT JWH MEDACTA INTERNATIONAL SA 02.07.0035RP 2112779 07630030815768

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention