BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE STEM

    MDR report key: 2926233 · Received January 16, 2013

    Report

    Report Number
    9616680-2013-90150
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL SURGERY FOR BHA DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23661 ACCOLADE STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 32492806

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention