BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP SCREW

    MDR report key: 6926572 · Received October 7, 2017

    Report

    Report Number
    0001825034-2017-08157
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    May 5, 2015
    Report Date
    November 28, 2017
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2015-02115, 0001825034-2015-02114. CONCOMITANT MEDICAL PRODUCTS: M2A 38 MM MOD HD +3 MM NK CATALOG# 11-173663 LOT 964290, M2A 1 PC SHELL 38 MM X 58 MM CATALOG# 15-105058 LOT# 570270, UNKNOWN HIP SCREW. 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

    ADDITIONAL MEDICAL RECORDS RECEIVED STATED, LAB WORK PRIOR TO THE REVISION SHOWED ELEVATED ION LEVELS. DURING THE REVISION IT A BROWNISH FLUID WAS ENCOUNTERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PATIENT ALLEGATIONS OF PAIN AND INSTABILITY. DURING THE PROCEDURE, IT WAS NOTED THAT A RIM SCREW WAS FRACTURED, BUT IT IS UNKNOWN IF IT BROKE DURING OR PRIOR TO REMOVAL. THE RIM SCREW DID NOT CAUSE ANY ISSUES. PATIENT WAS REVISED TO A COMPETITOR CUP AND BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706382 UNKNOWN HIP SCREW PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R