BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 6552801 · Received May 8, 2017

    Report

    Report Number
    0001822565-2017-03105
    Event Type
    Injury
    Date Received
    May 8, 2017
    Date of Event
    August 6, 2015
    Report Date
    May 8, 2017
    Manufacturer
    ZIMMER, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS CMP-0278892. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS. D11 - MEDICAL PRODUCTS - UNKNOWN HEAD P/N: NI L/N: NI; THERAPY DATE: NI

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "IS THERE A BENEFIT TO MODULARITY IN ¿SIMPLER¿ FEMORAL REVISIONS? ". IT WAS REPORTED THAT AN UNKNOWN NUMBER OF PATIENTS WITH A MONOBLOCK FEMORAL COMPONENT WERE REVISED DUE TO OSSEOINTEGRATION FAILURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333842 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE