BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 25268617 · Received May 25, 2026

    Report

    Report Number
    3005180920-2026-00488
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 25, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819957
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2026 LOT 171157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JULY-2017. EXPIRATION DATE: 2022-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 8.5 YEARS AFTER IMPLANTATION OF A TKA DUE TO LOOSENING OF THE TIBIAL COMPONENT. IN THE AVAILABLE RADIOGRAPHIC IMAGES, THE TIBIAL TRAY APPEARS MEDIALLY SHIFTED. THIS FINDING, TOGETHER WITH THE BONE IRREGULARITIES VISIBLE AT BOTH THE MEDIAL AND LATERAL MARGINS OF THE TIBIAL PLATEAU, MAY BE CONSISTENT WITH COMPONENT MOBILIZATION AND EVEN POSSIBLE SUBSIDENCE. IN ADDITION, RADIOLUCENT AREAS ARE APPRECIABLE AROUND THE TIBIAL COMPONENT, PARTICULARLY ON THE LATERAL PROJECTION, SUGGESTING LOSS OF FIXATION. ASEPTIC LOOSENING IS A WELL-DOCUMENTED ADVERSE EVENT FOLLOWING PRIMARY TKA AND IS DESCRIBED IN THE LITERATURE AS A MULTIFACTORIAL COMPLICATION WITH OFTEN UNCLEAR ETIOLOGY. POSSIBLE CONTRIBUTING FACTORS MAY INCLUDE BONE QUALITY, MECHANICAL LOADING, IMPLANT POSITIONING, FIXATION QUALITY, OR PATIENT-RELATED VARIABLES. BASED ON THE AVAILABLE INFORMATION, THE PRECISE ROOT CAUSE OF THIS FAILURE CANNOT BE DEFINITIVELY DETERMINED. AT PRESENT, THERE IS NO EVIDENCE TO SUGGEST A DEFECTIVE OR MALFUNCTIONING IMPLANT. ROOT CAUSE: 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.

    Description of Event or Problem · 0

    REVISION DUE TO TIBIAL TRAY LOOSENING ABOUT 8 YEARS AND 6 MONTHS AFTER PRIMARY. NO LOOSENING OF THE FEMORAL COMPONENT. NO INFECTION. EXPLANTATION OF THE TIBIAL TRAY AND INSERT. REIMPLANTATION OF A GMK-REVISION TIBIAL TRAY WITH WEDGES, OFFSET AND EXTENSION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213743 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIXED CEMENTED SIZE 6 R JWH MEDACTA INTERNATIONAL SA 02.07.1206R 171157 07630030819957

    Patients

    Seq Age Sex Outcome Treatment
    1