BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG)

    MDR report key: 1231912 · Received November 12, 2008

    Report

    Report Number
    9616680-2008-00378
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DESCRIBED ON CASE REPORT FORM AS "OPERATIVE SITE EVENT: EXCESSIVE HIP PAIN." THE EVENT OCCURRED POST-OP, IS DEVICE RELATED, BUT DID NOT MEET THE CRITERIA OF SERIOUS. IT WAS TREATED WITH BONE GROWTH STIMULATOR IN 2008, BONE SCAN WAS ORDERED FOUR MONTHS LATER, AND PSOAS TENDON INJECTION UNDER FLUORO TWO TIMES (2008). IT WAS ALSO NOTES THAT THE EVENT IS "POSSIBLY DUE TO SLOW BONE IN-GROWTH. BONE SCAN WAS ORDERED SINCE BONE GROWTH STIMULATOR AND INJECTIONS DID NOT HELP WITH PAIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE (127 DEG) IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25866801

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other