BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2962286 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00679
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF THE DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIDENT CLUSTER CUP 58. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD CERAMIC ON CERAMIC RIGHT HIP AND WAS REVISED DUE TO A LOOSE CUP AND WAS REVISED TO TRITANIUM REVISION WITH NEW POLY AND HEAD. STEM WAS WELL FIXATED AND WAS NOT REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD CERAMIC ON CERAMIC RIGHT HIP AND WAS REVISED DUE TO A LOOSE CUP AND WAS REVISED TO TRITANIUM REVISION WITH NEW POLY AND HEAD. STEM WAS WELL FIXATED AND WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65003 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R