BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORBIE QUESTOR TOTAL ELBOW

    MDR report key: 2439968 · Received February 6, 2012

    Report

    Report Number
    1043534-2012-00161
    Event Type
    Injury
    Date Received
    February 6, 2012
    Report Date
    January 12, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDB
    PMA / PMN Number
    K955099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND. PRODUCT NOT RETURNED.(B)(4)

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY PER ARTICLE "LONG-TERM EFFECTIVENESS OF SORBIE QUESTOR ELBOW ARTHROPLASTY: SINGLE SURGEON'S SERIES OF 15 YEARS" BY SORBIE, ET AL., ORTHOPEDICS. 2011 SEP 9; 34(9): E561-9, 7 PATIENTS WERE REVISED DUE TO HOSPITAL ACQUIRED INFECTIONS - 1 ALSO HAD SUBLUXATION AND 7 PREVIOUS OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORBIE QUESTOR TOTAL ELBOW SMALL JOINT COMPONENT JDB WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization