BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII NO-HOLE CUP. HA O.D 54MM FOR CERAMIC/CERAM

    MDR report key: 3955820 · Received August 31, 2012

    Report

    Report Number
    9616680-2012-00706
    Event Type
    Injury
    Date Received
    August 31, 2012
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. ASSOCIATED DEVICES: ABG II CERAMIC INSERT O.D. 52/54MM ID 28MM, CATALOG NUMBER 4930-7-039, LOT NUMBER GY484949; V40 ALUMINA FEMORAL HEAD 28MM V40 TAPER LONG, CATALOG NUMBER 4960-0-228, LOT NUMBER GY496522. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE ABGII CUP AND CERAMIC LINER WERE REMOVED BECAUSE THE PATIENT PRESENTED TO THE SURGEON WITH A PAINFUL RIGHT HIP OF 6 MONTHS DURATION WITH IRRITABILITY AND THE PATIENT DESCRIBED A FEELING OF BONE ON BONE. THE SURGEON REMOVED THE SHELL, LINER AND FEMORAL HEAD REPLACING THEM WITH A TRIDENT PSL SHELL, CERAMIC INSERT AND BIOLOX DELTA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII NO-HOLE CUP. HA O.D 54MM FOR CERAMIC/CERAM IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA GY492229

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R