BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IT XLPE LINER

    MDR report key: 7274764 · Received February 15, 2018

    Report

    Report Number
    0001822565-2018-00894
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 15, 2018
    Report Date
    January 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00875705600, CONTINUUM TM CUP, 62709635; 00875700001, DOME HOLE PLUG SINGLE PACK, 63713196; 51-114100, TPRLC 133 TYPE1 BM HO 10.0, 3943781; 650-0842, 36MM COCR BIOMET FEM HD +3 NK, 3945354. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP HAS BEEN REVISED APPROXIMATELY FIVE MONTHS POST IMPLANTATION DUE TO DISLOCATION AND INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117120 IT XLPE LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63595820

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R