BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/52

    MDR report key: 2252815 · Received September 13, 2011

    Report

    Report Number
    9616680-2011-00596
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 9616680-2011-00597.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAS PROXIMAL GMRS FEMUR, ADM INSERT AND HEAD REMOVED. DOCTOR PROCEEDED TO CONSTRAINED LINER BECAUSE OF MULTIPLE DISLOCATIONS. USED 2099 SERIES CONSTRAINED AND V-40 22MM HEAD. NO OTHER INFO PER HOSPITAL PROTOCOL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM X3 INS 28/52 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 33544101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention