BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/50

    MDR report key: 4200402 · Received October 24, 2014

    Report

    Report Number
    0002249697-2014-03985
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A DISLOCATION OF RIGHT HIP. OPEN REDUCTION REVEALED A DISASSOCIATED 28MM -4 V40 HEAD AND 28/50 ADM LINER. REPLACED WITH 28MM -4 HEAD AND 28/50 LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679705 RESTORATION ADM X3 INS 28/50 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R