BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA

    MDR report key: 22008375 · Received May 13, 2025

    Report

    Report Number
    3008021110-2025-00060
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 19, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    UDI-DI
    08033390092715
    PMA / PMN Number
    K141934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE STERILIZATION CHARTS NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE LOT NUMBERS INVOLVED. A FINAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE COMPLAINT SOURCE REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO A PERIPROSTHETIC INFECTION IN THE RIGHT KNEE. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. THE FOLLOWING DEVICES WERE EXPLANTED: · PHYSICA PS FEMUR COMP.RIGHT #8 (PRODUCT CODE: 6515.09.180, LOT: 17AS0T7 - STER. 2100167) - SOLD IN US · PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE: 6522.15.090, LOT: 2101104 - STER. 2100091)- SOLD IN US · PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE: 6535.50.910, LOT: 21AT19T - STER. 2100357) - SOLD IN US · PHYSICA TIBIAL STEM L.20MM (PRODUCT CODE: 6590.15.020, LOT: 2201697 - STER. 220009) - SOLD IN US PATIENT: MALE, 55 YEARS OLD. EVENT OCCURRED IN ITALY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370718 PHYSICA TIBIAL PLATE #9 JWH LIMACORPORATE S.P.A. FIXED TIBIAL PLATE 2101104 08033390092715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention