BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SMALL DURACON PATELLA TRIAL

    MDR report key: 2843638 · Received October 25, 2012

    Report

    Report Number
    2249697-2012-02076
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 28, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, LOANER DURACON PATELLAS TRIALS SENT IN FOR DR (B)(6). REVISION PATELLA CASE, SMALL PATELLA TRIAL PEG BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SMALL DURACON PATELLA TRIAL INSTRUMENT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other