BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS LIPPED TIBIA INSERT MED 13

    MDR report key: 1040203 · Received May 8, 2008

    Report

    Report Number
    9616680-2008-00116
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HSH
    PMA / PMN Number
    K012172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT COMPLAINED OF PAIN OCCURRING IN KNEE JOINT SOMETIME IN PAST MONTH. X-RAYS REVEALED LOOSE SCREW FLOATING IN KNEE JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS LIPPED TIBIA INSERT MED 13 IMPLANT HSH STRYKER ORTHOPAEDICS CORK NA LBBX

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention