BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERALIZED MALLORY/HEAD PF FEMORAL 13X170 MM STEM

    MDR report key: 7096182 · Received December 7, 2017

    Report

    Report Number
    0001825034-2017-10992
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): A 11-104213 322690 MLRY-HD LAT POR FMRL 13X170MM. AR-122858 2470769 EXC ABT CMTD ARC ML CUP 28X58. A 163661 0000717431 28MM DIA COCR MOD HD -3MM NK. REPORT SOURCE: COUNTRY: (B)(6). 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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 · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876542 LATERALIZED MALLORY/HEAD PF FEMORAL 13X170 MM STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 322690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R