BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 INSERT TRIAL 32MM

    MDR report key: 2212097 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01022
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THEATRE (B)(6) REPORTED TO THE MHRA THE FOLLOWING: "TRIAL REDUCTION OF HIP WAS PERFORMED USING TRIAL PROSTHESIS. ON REMOVAL OF CUP, IT WAS NOTICED THAT THERE WERE TWO CHIPS MISSING FROM THE EDGE OF THE TRIAL. THE SURGEON WAS ABLE TO FIND AND RETRIEVE ONE, BUT WAS UNABLE TO FIND THE SECOND PIECE." HE ADDED THAT THERE WAS NO INJURY TO THE PT AND THAT THE ITEM HAS BEEN TAKEN OUT OF USE AND THAT THE SURGEON THOROUGHLY WASHED OUT THE HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 INSERT TRIAL 32MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 75694401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other