BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA

    MDR report key: 25094526 · Received May 6, 2026

    Report

    Report Number
    3008021110-2026-00213
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 4, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    UDI-DI
    08033390089920
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE DEVICES RELEASED WITH THE LOT N. INVOLVED. THIS IS THE FIRST AND ONLY COMPLAINT RECORDED ON THIS LOT N. (2200885). A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO ASEPTIC MOBILIZATION, PERFORMED ON (B)(6) 2026. THE PREVIOUS SURGERY WAS CARRIED OUT IN 2022. PATIENT IS FEMALE, 75 YEARS OLD. THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595815 PHYSICA FIXED TIBIAL PLATE JWH LIMACORPORATE S.P.A. 6522.15.050 08033390089920

    Patients

    Seq Age Sex Outcome Treatment
    1