BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TOTAL LEFT KNEE

    MDR report key: 2885230 · Received December 18, 2012

    Report

    Report Number
    2249697-2012-02735
    Event Type
    Injury
    Date Received
    December 18, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, INFECTED LEFT TOTAL KNEE. REMOVAL OF TOTAL ARTHROPLASTY COMPONENTS LEFT KNEE. INSERTION OF ANTIBIOTICS AND ARTICULATING SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TOTAL LEFT KNEE IMPLANT MEH STRYKER ORHTOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR