BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP-DUMMY IMPLANT

    MDR report key: 2212790 · Received August 16, 2011

    Report

    Report Number
    1020279-2011-00332
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE AREAS OF DAMAGE, POSSIBLY FROM EXTRACTION, WERE OBSERVED ON THE FACE OF THE LINER. IN ADDITION, PLASTIC DEFORMATION, LIKELY DUE TO NECK IMPINGEMENT, WAS OBSERVED ON THE FACE . NO UNUSUAL WEAR FEATURES WERE SEEN ON ARTICULAR SURFACE OF THE ACETABULAR LINER. CASES INVOLVING SIMILAR AMOUNTS OF LINEAR PENETRATION HAVE BEEN REPORTED IN THE LITERATURE WITH ZIRCONIA HEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO WEAR OF LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP-DUMMY IMPLANT JDH SMITH & NEPHEW, ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R