BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3023992 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01138
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2011
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TIBIAL BASEPLATE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT (B)(6). MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING INSTABILITY INVOLVING AN UNKNOWN BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE ARTHOPLASTY WAS REVISED DUE TO MALPOSITION AND INSTABILITY. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~4.5 Y. THE FEMORAL CONDYLES, PATELLA, TIBIAL TRAY, AND POLYETHELENE TIBIAL INSERT WERE REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO MALPOSITION AND INSTABILITY. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~4.5 Y. THE FEMORAL CONDYLES, PATELLA, TIBIAL TRAY, AND POLYETHYLENE TIBIAL INSERT WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126716 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention