BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT KEE-BICOMP

    MDR report key: 6436165 · Received March 27, 2017

    Report

    Report Number
    0002249697-2017-01025
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 27, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SUBJECT STATED REVISION DUE TO LOOSENING. REVISION SURGERY WAS PERFORMED IN (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219135 UNKNOWN RIGHT KEE-BICOMP KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R