BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSL M/S 3-HOLE CUP

    MDR report key: 2090188 · Received May 6, 2011

    Report

    Report Number
    2249697-2011-00668
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDJ
    PMA / PMN Number
    K925883
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DUE TO PAIN AND POLY WEAR THE CUP WAS REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSL M/S 3-HOLE CUP IMPLANT JDJ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R