BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. FEMORAL STEM WITH HYDROXYAPATITE RIGHT

    MDR report key: 2070994 · Received April 20, 2011

    Report

    Report Number
    9616680-2011-00226
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    November 16, 2010
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ABG II WITH CERAMIC/CERAMIC WAS IMPLANTED INTO THE PT IN 2004. DUE TO SQUEAKING THE CUP WAS REVISED ON (B)(6) 2007. IN (B)(6) 2010, THE STEM BROKE AND WAS REVISED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. FEMORAL STEM WITH HYDROXYAPATITE RIGHT IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention