BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTER STEM

    MDR report key: 2171355 · Received July 18, 2011

    Report

    Report Number
    9610726-2011-00257
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    FOUR YEAR AGO, PT HAD AN EXETER TRIDENT IMPLANTED. PT HAD A COLLECTION OF PUS ON THE ANTERIOR ASPECT OF THE HIP. THIS WAS DRAINED AND ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC HIP SPACER WAS IMPLANTED WITH BEADS. THESE WERE SUBSEQUENTLY REMOVED ON (B)(6) 2011 AND A RESTORATION MODULAR CONE CONICAL STEM, V40 FEMORAL HEAD, TRITANIUM SHELL AND 10 DEGREE POLY LINER WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTER STEM IMPLANT JDI STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention