BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10 INSERT TRIAL 36MM

    MDR report key: 2823882 · Received October 10, 2012

    Report

    Report Number
    2249697-2012-01827
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WHILE TRIALING DURING A PRIMARY LEFT HIP CASE, THE SURGEON WAS INSERTING A 36E 10 DEGREE TRIAL LINER AND THE PLASTIC CRACKED WHILE THE SURGEON WAS INSERTING FOR TRIAL. SURGEON HAD ANOTHER TRIAL AVAILABLE AND USED A NEW LINER AND COMPLETED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 10 INSERT TRIAL 36MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 902MJD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other