BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 7216791 · Received January 24, 2018

    Report

    Report Number
    0001825034-2018-00414
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    November 4, 2016
    Report Date
    January 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00413, 0001825034-2018-00415. CONCOMITANT MEDICAL PRODUCTS: 28MM MOD HD STD NECK TP1 TAPER CATALOG#: 163662 LOT#: NI, M/H SLD/APX HLE RNGLC SHL 58MM CATALOG#: 11-104058 LOT#: NI, UNKNOWN STEM CATALOG#: NI LOT#: NI. (B)(6). 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 THAT A PATIENT HAD A TOTAL HIP REVISION SURGERY APPROXIMATELY 9 YEARS POST PRIMARY SURGERY, DUE TO SUBLUXATION AND LUXATIONS. DURING THE REVISION, CUP, LINER AND HEAD 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
    60861 UNKNOWN LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1