BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT

    MDR report key: 21966608 · Received May 6, 2025

    Report

    Report Number
    3008021110-2025-00046
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 6, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBH
    UDI-DI
    08033390174305
    PMA / PMN Number
    K201084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE COMPONENT WITH LOT NUMBER 2212388, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE (B)(4) ITEMS BELONGING TO THIS LOT NUMBER. THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY ON (B)(6) 2025, DUE TO FAILED POROUS LIMA TIBIAL COMPONENT: TIBIA COLLAPSED AND NEEDED FULL REVISION. THE FOLLOWING COMPONENTS WERE REVISED:Z - PHYSICA PS - FEMORAL PEG (PART CODE 6515.09.900, LOT NUMBER 2322178, STERILIZATION 2300215). - PS FEMORAL COMPONENT #8 RIGHT (PART CODE 6515.10.180, LOT NUMBER 2316633, STERILIZATION 2300195). - PHYSICA TT FIX. TIBIAL TRAY #7 (PART CODE 6521.14.070, LOT NUMBER 2212388, STERILIZATION 2200277). - PHYSICA PS TIBIAL LINER #7 (PART CODE 6535.50.710 , LOT NUMBER 22BC06J, STERILIZATION 2200263). - PATELLAR PROSTHES.D.38 H.10MM (PART CODE 6595.54.038, LOT NUMBER 22AT1V6, STERILIZATION 2300228). THE REMOVED DEVICES WERE REPLACED BY THIRD-PARTY COMPONENTS. SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68953 PHYSICA TT PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED MBH LIMACORPORATE S.P.A. 6521.14.070 2212388 08033390174305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention