BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3233496 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02370
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION SURGERY OCCURRED DUE TO SUSPICION OF A LOOSE FEMORAL COMPONENT. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A FEMORAL PERIPROSTHETIC FRACTURE. IT WAS NOTED THAT THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REPLACED. AS NO DEFICIENCIES ARE REPORTED FOR THE UNKNOWN TIBIAL INSERT AND UNKNOWN TIBIAL BASEPLATE, IT IS BELIEVED THE REPORTED DEVICES ARE CONCOMITANT. IT IS LIKELY THAT THE INSERT AND BASEPLATE WERE REPLACED DUE TO DAMAGE THAT MAY HAVE OCCURRED WHEN TRYING TO GAIN ACCESS TO THE FEMORAL COMPONENT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO PRODUCT INFORMATION WAS PROVIDED, THE REPORTED DEVICE WAS NOT RETURNED FOR INSPECTION, AND INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS ARE UNKNOWN AT THIS TIME. THE DEVICES WERE REPORTED AS AN UNKNOWN FEMORAL COMPONENT, UNKNOWN TIBIAL BASEPLATE AND UNKNOWN TIBIAL INSERT. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TS SUBJECT WAS HAVING THEIR PRIMARY STRYKER TRIATHLON PS KNEE REVISED. X-RAYS HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TS SUBJECT WAS HAVING THEIR PRIMARY STRYKER TRIATHALON PS KNEE REVISED. X-RAYS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336284 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention