BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 7267200 · Received February 13, 2018

    Report

    Report Number
    0001822565-2018-00854
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    February 13, 2017
    Report Date
    February 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. CONCOMITANT MEDICAL PRODUCTS: ACT ARTIC E1 HIP BRG 28X54MM CATALOG#: EP-200160 LOT#: 950150, G7 OSSEOTI MULTIHOLE 66MM I CATALOG#: 110010271 LOT#: R3714016A, G7 DUAL MOBILITY LINER 54MM I CATALOG#: 110024467 LOT#: 879310, UNKNOWN STEM CATALOG#: NI LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 A PATIENT HAD A RIGHT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE ARTICULATING COMPONENTS WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112058 UNKNOWN HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R