BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3103056 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01596
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 8, 2005
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION, HISTORY REVIEW OR COMPLAINT HISTORY WAS PERFORMED AS NO DEVICES WERE RECEIVED OR IDENTIFIED. NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE REPORTED EVENT REGARDING PAIN POST TRAUMA LEADING TO A REVISION INVOLVING AN UNKNOWN CERAMIC LINER WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN CERAMIC COMPONENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RETROSPECTIVE STUDY THAT THERE WAS PAIN POST TRAUMA WHICH RESULTED IN THE REVISION OF CERAMIC COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RETROSPECTIVE STUDY THAT THERE WAS PAIN POST TRAUMA WHICH RESULTED IN THE REVISION OF CERAMIC COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203371 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R