BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA ACE/DEEP SOCKET SHELL 55MM

    MDR report key: 2801429 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01933
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K852153
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE ORIGINAL SHELL BECAME LOOSE. THE ORIGINAL CUP, LINER, AND HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA ACE/DEEP SOCKET SHELL 55MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA SKNSB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention