BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PCA MEDIUM TIBIAL COMPONENT

    MDR report key: 2426335 · Received January 18, 2012

    Report

    Report Number
    2249697-2012-00059
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 28, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS REVISED DUE TO A FRACTURED TIBIAL COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PCA MEDIUM TIBIAL COMPONENT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention