BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION MODULAR

    MDR report key: 2190402 · Received July 28, 2011

    Report

    Report Number
    9616680-2011-00495
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. DEVICE WAS DISCARDED. ADD'L INFO (X-RAYS, MEDICAL RECORDS, OPERATIVE NOTES, DEVICE DETAILS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE RESTORATION MODULAR HAS FRACTURED ON THE PROXIMAL END OF THE DISTAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION MODULAR IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention