BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM 12/14 TPR FEM HD STD NK

    MDR report key: 8411242 · Received March 12, 2019

    Report

    Report Number
    3002806535-2019-00253
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    February 26, 2016
    Report Date
    March 12, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: EXC ABT CMTD ARC MLCUP 32X54 , CATALOG #:AR-123254 , LOT #: 3395492; MEDICAL PRODUCT: OLYMPIA STEM SIZE 4 RIGHT, CATALOG #: 650-0634, LOT #: 3233405. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00252, 3002806535-2019-00254. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    HIP REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205400 32MM 12/14 TPR FEM HD STD NK HIP PROSTHESIS LZO BIOMET UK LTD. N/A 3448881

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R