BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII NO3 CEMENTLESS RIGHT V40

    MDR report key: 2210078 · Received August 3, 2011

    Report

    Report Number
    9616680-2011-00509
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO THE BREAKAGE OF THE STEM INVOLVED. THE SURGEON REPORTED THAT THE STEM BROKE BELOW THE NECK OF THE DEVICE, WHILE THE PT WAS IN AN UPRIGHT POSITION. THE SURGEON'S OPINION IS THAT THERE WAS A SUBSIDENCE BECAUSE OF UNDERSIZED STEM, MOREOVER, THE PT DESCRIBED THAT HE HEARD A METALLIC SOUND DURING THE ABDUCTION. IT WAS NOTED BY THE SURGEON THAT THE PT HAS ONE LIMB SHORTER THAN THE OTHER OF ABOUT 1.5 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII NO3 CEMENTLESS RIGHT V40 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2943705E

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention