BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM

    MDR report key: 7546129 · Received May 25, 2018

    Report

    Report Number
    0001822565-2018-02869
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    January 22, 2018
    Report Date
    May 24, 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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00610505028, ITEM NAME: STANDARD LINER, LOT #: UNKNOWN. ITEM NUMBER: 00902602900 , ITEM NAME: FEMORAL HEAD, LOT #: 6120900. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN CUP, LOT #: UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND PHOTOGRAPHS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-00865, 0001822565-2018-02867.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY THIRTEEN YEARS POST-IMPLANTATION DUE TO CHRONIC DISLOCATION, PAIN AND IMPLANT NOISE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388730 FEMORAL STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other