BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD

    MDR report key: 7330792 · Received March 12, 2018

    Report

    Report Number
    0001825034-2018-01752
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 5, 2018
    Report Date
    April 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    CMP-(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: EP-105995, ITEM NAME: RINGLOC LINER, LOT #: 202850. ITEM NUMBER: 16-104158, ITEM NAME: RINGLOC SHELL, LOT #: 579340. ITEM NUMBER: 51-107130, ITEM NAME: TAPERLOC STEM, LOT #: 6170548.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION DUE TO DISLOCATION ON THE SAME DAY AS INITIAL SURGERY. THE FEMORAL HEAD COMPONENT WAS REVISED TO THE SAME SIZE, BUT WITH INCREASED OFFSET. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174563 COCR HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 857130

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R