BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4712555 · Received April 21, 2015

    Report

    Report Number
    0002249697-2015-01284
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN ACCOLADE HFX STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. SURGEON SENDING TO (B)(4) LAB.

    Description of Event or Problem · 1

    RIGHT HIP REVISION FOR PAIN POSSIBLY RELATED TO COBALT CORROSION. ACCOLADE HFX STEM AND HEAD EXPLANTED AND REPLACED WITH A ZIMMER WAGNER STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263218 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention