BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3961601 · Received July 28, 2014

    Report

    Report Number
    0002249697-2014-02876
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN DURACON PATELLA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A DURATION PATELLA WAS REPORTED. CONCLUSION: THE REPORTED EVENT INDICATES A REVISION OF THE INSERT AND PATELLA DUE TO LAXITY. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LAXITY. SURGEON HAD IMPLANTED A (B)(4) PATELLA TRIATHLON X3 AND (B)(4) INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LAXITY. SURGEON HAD IMPLANTED A 5550-G-360 PATELLA TRIATHLON X3 AND 6642-1-722 INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439411 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R