BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCRMO FEMORAL HEAD

    MDR report key: 21291352 · Received February 3, 2025

    Report

    Report Number
    3008021110-2025-00001
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 3, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWZ
    UDI-DI
    08033390006781
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO PRE-EXISTING ANOMALY WAS DETECTED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER 2224900 - STERILIZATION 2200308. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO IMPLANT DISLOCATION. THE FOLLOWING COMPONENT (IMPLANTED DURING THE PREVIOUS SURGERY) WAS REMOVED: FEM. MODULAR HEAD - S Ø28MM (PART CODE 5010.09.281, LOT NUMBER 2224900, STERILIZATION 2200308) THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024. DURING THIS SURGERY, THE FOLLOWING COMPONENT WAS ALSO IMPLANTED ALONG WITH THE OTHERS: H-MAX S LATERAL. FEM. STEM #12 (PART CODE 4251.20.120, LOT NUMBER 2000921, STERILIZATION 2000047). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6). THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116496 COCRMO FEMORAL HEAD MODULAR FEMORAL HEADS (COCRMO) DIA. 28MM S TAPER 12/14 KWZ LIMACORPORATE S.P.A. 5010.09.281 2224900 08033390006781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention