BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICA TT

    MDR report key: 25238766 · Received May 21, 2026

    Report

    Report Number
    3008021110-2026-00227
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    December 4, 2025
    Report Date
    May 19, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JWH
    UDI-DI
    08033390169912
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHECK OF DHRS OF THE INVOLVED LOT NUMBER 2211436 DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALIES ON THE ITEMS MANUFACTURED WITH THIS LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 REVISION OF KNEE PROTHESIS DUE TO SINTERING OF PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT: 2211436 - STER: (B)(4). DURING REVISION THE TOTAL PRIMARY KNEE HAS BEEN CHANGED TO A ROTATING HINGED KNEE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. DURING ONE YEAR-CONTROL ONLY MINOR RADIOLOGIC SIGNS OF SINTERING SHOWED UP. INCREASING SINTERING WITHIN THE SECOND YEAR OF POST-OP. PATIENT DID NOT REPORT ANY TRAUMA. PRODUCT CODES AND LOT NUMBERS OF THE OTHER DEVICES IMPLANTED ON THE FIRST SURGERY ON 2023: PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT: 2211436 - STER: (B)(4), PS FEMORAL COMPONENT #5 LEFT (PRODUCT CODE: 6515.10.550, LOT: 2222424 - STER: (B)(4), PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE: 6535.50.511, LOT: 22BC069 - STER: (B)(4), PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT: 2313310 - STER: (B)(4). PATIENT: FEMALE, 75 YEARS OLD, APPROXIMATE HEIGHT 1.65(M), APPROXIMATE WEIGHT 58 (KG), ACTIVE LEVEL, NO SMOKING. EVENT OCCURRED IN AUSTRIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129115 PHYSICA TT PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #5 UNCEMENTED JWH LIMACORPORATE S.P.A. 6521.14.050 2211436 08033390169912

    Patients

    Seq Age Sex Outcome Treatment
    1