BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2924575 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00114
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS A DUPLICATE OF MF REPORT # 2249697-2013-00031, (B)(4).

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER REJUVENATE HIP REPLACEMENT NECK. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT HAS INJURIES SUSTAINED AS A RESULT OF THE IMPLANTATION OF A STRYKER REJUVENATE HIP REPLACEMENT".

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT HAS INJURIES SUSTAINED AS A RESULT OF THE IMPLANTATION OF A STRYKER REJUVENATE HIP REPLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30834 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other