BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/O

    MDR report key: 1823805 · Received August 30, 2010

    Report

    Report Number
    2249697-2010-01162
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K021310
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WHILE RESTOCKING ON (B)(6) 2010, REP INFORMED ME THAT I HAD USED A C-TAPER HEAD WITH AN ACCOLADE STEM ON PATIENT. I IMMEDIATELY CONTACTED DR (IN PERSON) AND EXPLAINED MY ERROR. HE WILL DISCUSS CORRECTING THE SITUATION WITH THE PATIENT ON MON (B)(6) 2010."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 36MM/O IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA NN9MTA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other