BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 1900033 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01512
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2010-01513.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD PAIN, IT APPEARED ON THE X-RAY THAT THE BASEPLATE WAS LOOSE. DOCTOR TOOK OUT POLY INSERT AND AT WHICH TIME HE PUT THE EXTRACTOR ONTO THE BASEPLATE AND WIGGLED IT AND THE BASEPLATE WAS LOOSE IT CAME RIGHT OUT. THERE WAS NO CEMENT ON THE BASEPLATE, ALL THE CEMENT WAS LEFT ON THE BONE. THE PATELLA BUTTON DURING SURGERY WHEN HE WAS CUTTING THE TIBIA HE ACCIDENTALLY CUT A MARK ON THE PATELLA AND HE DECIDED AT THAT POINT HE HAD TO REPLACE THE PATELLA TOO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention