BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 7501964 · Received May 10, 2018

    Report

    Report Number
    0001825034-2018-03279
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    June 13, 2013
    Report Date
    May 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). REPORTED EVENT WAS CONFIRMED BY THE REVIEW OF OP NOTES AND X-RAYS. 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. CONCOMITANT MEDICAL PRODUCTS: ITEM # EP-200144, LINER, LOT # 041270; ITEM # 11-301302, STEM, LOT # 084750. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03279, 0001825034-2018-01077, 0001825034-2018-01078.

    Additional Manufacturer Narrative · 1

    EVENT PREVIOUSLY REPORTED AS A MALFUNCTION IN ERROR. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS AND FAILED MULTIPLE CONSERVATIVE TREATMENTS. INTRA-OPERATIVELY, A GROSSLY UNSTABLE HIP WITH LOTS OF HEMATOMA AS WELL AS A GREATER TROCHANTER FRACTURE WAS IDENTIFIED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345535 CER BIOLOXD OPTION HD 28MM HIP PROSTHESIS LZO ZIMMER BIOMET, INC. N/A 190320

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R