BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABII. MODULAR STEM

    MDR report key: 2062558 · Received April 7, 2011

    Report

    Report Number
    9616680-2011-00179
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    K092400
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DR. (B)(6), IMPLANT SURGEON AT THE HOSPITAL, REPORTED THAT THE DEVICES HAD TO BE REMOVED BECAUSE OF "GROIN PAIN AND INCREASED BLOOD CO LEVEL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABII. MODULAR STEM IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA G1514988

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention