BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM RNGLC LNR 22MM HWALL 20

    MDR report key: 7332703 · Received March 12, 2018

    Report

    Report Number
    0001825034-2018-01809
    Event Type
    Injury
    Date Received
    March 12, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 163652, 22.2MM DIA COCR MOD HD -5 NK, 386610, 106042, RAN/BUR RNGLC SHL 42MM SZ 20, 186280, X11-180311, BI-METRIC/X POR NC LAT 11X135, 122930, 103531, TI LOW PROFILE SCREW 6.5X20MM, 406540, 103531, TI LOW PROFILE SCREW 6.5X20MM, 216950. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175320 ARCOM RNGLC LNR 22MM HWALL 20 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 294200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O