BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3984194 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03023
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN SIZE 8 X 12MM SECURE FIT PLUS. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT HIP DUE TO STEM BREAKAGE AND STEM SUBSIDENCE. DOCTOR REMOVED SIZE 8 X12MM SECUREFIT PLUS, SIZE 32MM +5 ALUMINA CERAMIC HEAD AND SIZE 32MM + 6 ESSENTIAL CROSSFIRE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461906 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention