BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED KNEE IMPLANT OR INSTRUMENT

    MDR report key: 2955236 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12128
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    DEPUY SYNTHES
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    REVISION OF SIZE 4 PFC POLY CR FIXED BEARING TO A THICKER POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59946 UNIDENTIFIED KNEE IMPLANT OR INSTRUMENT POLY TIBIAL INSERT JWH DEPUY SYNTHES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention