BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 2061227 · Received April 11, 2011

    Report

    Report Number
    9616680-2011-00193
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "FAILED ACCOLADE TMZF STEM ORIGINALLY PUT IN 2007 WAS TAKEN OUT ON 03/21/2011. PT HAS BILATERAL HIP OTHER SIDE IS FINE, ALSO DONE 2007 CUP AND LINER STAYED IN JUST REVISED HEAD AND STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 22868301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention