BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERSONA POSTERIOR STABILIZED FEMORAL COMPONENT

    MDR report key: 5670887 · Received May 20, 2016

    Report

    Report Number
    3007963827-2016-00034
    Event Type
    Death
    Date Received
    May 20, 2016
    Date of Event
    January 15, 2016
    Report Date
    April 22, 2016
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE PATIENT'S DEATH. ZIMMER CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS NOW REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY EIGHT MONTHS FOLLOWING KNEE ARTHROPLASTY. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324663 PERSONA POSTERIOR STABILIZED FEMORAL COMPONENT JWH JWH ZIMMER ORTHOPAEDIC MFG. LTD. 62753867

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death