BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 6 ACCOLADE II 127 DEG

    MDR report key: 2901590 · Received January 3, 2013

    Report

    Report Number
    9616680-2013-90008
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K120578
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STEM SUBSIDED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316 SIZE 6 ACCOLADE II 127 DEG IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 41213801

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R