BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION ALL POLY PAT LG

    MDR report key: 2234024 · Received August 29, 2011

    Report

    Report Number
    9616680-2011-00563
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WIL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATELLA WAS REVISED DUE TO FAILED PATELLA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION ALL POLY PAT LG IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 00188960

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention