BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS SO 15X150MM

    MDR report key: 20599661 · Received November 4, 2024

    Report

    Report Number
    0001825034-2024-02579
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 13, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00880304491861
    PMA / PMN Number
    K200196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-0661 ITEM NAME DELTA CERAMIC FEM HD 36/0MM LOT # 3192267. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE A DUPLICATE OF ANOTHER COMPLAINT PREVIOUSLY REPORTED UNDER MFR # 0001825034-2024-02557. REFER TO MFR # 0001825034-2024-02557 FOR REPORTED EVENT GOING FORWARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A PERIPROSTHETIC FRACTURE WHICH RESULTED FROM A FALL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE A DUPLICATE OF ANOTHER COMPLAINT PREVIOUSLY REPORTED UNDER MFR # 0001825034-2024-02557. REFER TO MFR # 0001825034-2024-02557 FOR REPORTED EVENT GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632069 TPRLC 133 T1 PPS SO 15X150MM PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A J7485290 00880304491861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H PLEASE SEE H11