BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM

    MDR report key: 2436624 · Received February 2, 2012

    Report

    Report Number
    1020279-2012-00058
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOP LINER RING HAD SIGNS OF PLASTIC DEFORMATION ON THE INNER RIM WAS LIKELY DUE TO FEMORAL HEAD/NECK IMPINGEMENT. THIS IMPINGEMENT WHEN COUPLED WITH LEVER-OUT FORCES, WHICH MAY HAVE BEEN GENERATED DURING THE REPORTED DISLOCATION, LIKELY RESULTED IN THE DISASSOCIATION OF THE TOP LINER RING AND THE INNER FEMORAL HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM BIPOLAR JDH SMITH & NEPHEW, INC. 04JM13160

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R