BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB SM 9

    MDR report key: 2922145 · Received January 14, 2013

    Report

    Report Number
    9616680-2013-90113
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS CORK
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. (B)(6) STATED THE PT COMPLAINED OF PROGRESSIVE LOOSENESS OF HER KNEE. A POLY LINER WAS EXCHANGED. PT WANTED IMPLANT. DR WAS HAPPY WITH POST OP STABILITY OF KNEE AFTER POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20859 DURA DURATION A/P TIB SM 9 IMPLANT MBH STRYKER ORHTOPAEDICS CORK NA 05354801

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other