BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXF UNI TIB TRAY SZ C RM PMA

    MDR report key: 7999710 · Received October 24, 2018

    Report

    Report Number
    3002806535-2018-01152
    Event Type
    Death
    Date Received
    October 24, 2018
    Date of Event
    January 10, 2018
    Report Date
    October 24, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    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). CONCOMITANT MEDICAL PRODUCT - OXFORD UNI FEMORAL SM , ITEM 1546003, LOT 1577925. THERAPY DATE - DEVICE REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCT - OXF ANAT BRG RT SM SIZE 4 PMA, ITEM 159569, LOT 1443137. THERAPY DATE - DEVICE REMAINS IMPLANTED. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01151 AND 3002806535-2018-01153.

    Description of Event or Problem · 1

    PATIENT DIED AND CAUSE OF DEATH UNKNOWN. IMPLANT WAS IN PLACE UPON LAST CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842571 OXF UNI TIB TRAY SZ C RM PMA OXFORD CEMENTED TIBIAL TRAYS HRY BIOMET UK LTD. 1464608

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR