BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 28MM/+5

    MDR report key: 1915646 · Received December 1, 2010

    Report

    Report Number
    2249697-2010-01638
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K933359
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR.# 9616680-2010-00791.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS DISLOCATING SO, REVISED THE LINER AND HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 28MM/+5 IMPLANT LWJ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention