BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/-5

    MDR report key: 1932953 · Received December 15, 2010

    Report

    Report Number
    2249697-2010-01745
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON SAID PATIENT DISLOCATED HAS COMPETITOR PINNACLE CUP. HE REMOVED HEAD AND LINER. REPLACED HEAD (RESTORATION HA CALCAR STEM) AND PUT IN COMPETITOR CONSTRAINED LINER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 36MM/-5 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA 14327102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R