BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII MODULAR SHORT NECK

    MDR report key: 2871978 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01322
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K0924206
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES WERE NOT AVAILABLE FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS COMPLAINING OF INCREASED HIP PAIN RECENTLY. THE SURGEON AND PT AGREED TO REVISE THE STEM. STEM WAS REMOVED USING OSTEOTOMES AND BURR. THE SURGEON REPORTED A BLACKISH RESIDUE AROUND THE NECK OF THE STEM. THE SURGEON PROCEEDED TO REVISE HIP WITH A SECUREFIT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII MODULAR SHORT NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2985277

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R