BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVON PAT/FEM JOINT EX SMALL

    MDR report key: 2202395 · Received August 4, 2011

    Report

    Report Number
    9610726-2011-00277
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRR
    PMA / PMN Number
    K041160
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT WAS HAVING PAIN SO THE AVON PATELLA WAS REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVON PAT/FEM JOINT EX SMALL IMPLANT KRR STRYKER ORTHOPAEDICS LIMERICK NA SFSXF

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention