BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 7957557 · Received October 11, 2018

    Report

    Report Number
    0001825034-2018-09667
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    October 3, 2012
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, UNKNOWN LINER, LOT# UNKNOWN; ITEM# 157444, UNKNOWN HEAD, LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS WHICH INDICATED THE ACETABULAR COMPONENT WAS AFFIXED BY SURGICAL SCREWS, ONE OF WHICH SLIGHTLY TRAVERSES THE MEDIAL WALL OF THE ACETABULUM. DEVICE HISTORY RECORD (DHR) 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05070- 1, 0001825034 - 2018 -05072 -1. 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 UNDERWENT LEFT HIP REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO INSTABILITY AND MULTIPLE SUBLUXATIONS/DISLOCATION. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797278 UNKNOWN SCREW PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R