BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MODULAR HEAD COCR

    MDR report key: 6974343 · Received October 24, 2017

    Report

    Report Number
    0001825034-2017-08844
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    March 14, 2016
    Report Date
    January 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ARCOM XL LINER, CATALOG #: XL-108222, LOT #: 392250 ; UNIVERSAL RINGLOC 2-HOLE SHELL, CATALOG#: 14-103648, LOT #: 835910. ORIGINAL AWARE DATE (B)(6) 2017. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST-IMPLANTATION DUE TO MALPOSITIONING. THE HEAD WAS EXCHANGED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751602 32MM MODULAR HEAD COCR PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 124190

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R