BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P4 28MM 10 DEGREE +4MM INSERT

    MDR report key: 2150603 · Received June 23, 2011

    Report

    Report Number
    9616680-2011-00418
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K903362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. D4 - CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6260-5-128 LOT # UNK, DESCRIPTION: 28MM STD V40 TAPER VIT HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    REVISION SURGERY TO CORRECT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P4 28MM 10 DEGREE +4MM INSERT IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA XYVWA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other