BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ L

    MDR report key: 7998924 · Received October 24, 2018

    Report

    Report Number
    3002806535-2018-01148
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 30, 2016
    Report Date
    October 23, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - OXF UNI CMNTLS TIB SZ F LM, ITEM 166580, LOT 1256028, THERAPY DATE - DEVICE REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCT - OXF ANAT BRG LT LG SIZE 4 PMA, ITEM 159555, LOT 1220227, 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: 3002806535-2018-01147 AND 3002806535-2018-01149.

    Description of Event or Problem · 1

    PATIENT DIED AND CAUSE OF DEATH IS UNKNOWN. TO THE BEST OF OUR KNOWLEDGE THE IMPLANTS REMAINED IN SITU AT THE DATE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841468 OXFORD PH3 CEMENTLESS FEM SZ L OXFORD CEMENTLESS FEMORALS NRA BIOMET UK LTD. 918778

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR