BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFECTA(R) PDA STEM COCR

    MDR report key: 3515640 · Received December 11, 2013

    Report

    Report Number
    1043534-2013-02553
    Event Type
    Injury
    Date Received
    December 11, 2013
    Report Date
    November 11, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    PMA / PMN Number
    K915795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW WAS CONDUCTED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    AS PER WECHTER, J., ET AL., CLIN ORTHOP RELAT RES, 2013. 471(11): P. 3588-95. "IMPROVED SURVIVAL OF UNCEMENTED VERSUS CEMENTED FEMORAL STEMS IN PATIENTS AGED < 70 YEARS IN A COMMUNITY TOTAL JOINT REGISTRY.": THIRTEEN CEMENTED PERFECTA PDA STEMS (PROBABLY PDA COCR) WITHIN THE HEALTHEAST REGISTRY WERE REVISED. PATIENT DETAILS, OTHER COMPONENT DETAILS, AND REASONS FOR REVISION WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646961 PERFECTA(R) PDA STEM COCR HIP COMPONENT, CODE:JDI JDI WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention