BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS ULNA COMPONENT, RIGHT, 140MM CEMENTED DISTAL, POROUS COATING PROXIMAL

    MDR report key: 3120485 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01711
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    March 17, 2012
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED THERE IS NO EVIDENCE THAT THIS CLINICAL SITUATION WAS THE RESULT OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS. THE EVENT WAS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT IS NOT RELATED TO MANUFACTURING FACTORS. RATHER, IT IS USER RELATED.

    Description of Event or Problem · 1

    POSTOPERATIVE THE SURGEON REALIZED THAT THE INSTRUMENTS USED TO PREPARE THE ULNA WERE NOT USED PROPERLY. SUBSEQUENTLY A REVISION WILL BE NECESSARY.

    Description of Event or Problem · 1

    POSTOPERATIVE THE SURGEON REALIZED THAT THE INSTRUMENTS USED TO PREPARE THE ULNA WERE NOT USED PROPERLY. SUBSEQUENTLY A REVISION WILL BE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221927 MRS ULNA COMPONENT, RIGHT, 140MM CEMENTED DISTAL, POROUS COATING PROXIMAL IMPLANT HRS STRYKER ORTHOPAEDICS-MAHWAH MLD88T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other