BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER TRIAL HEAD 36MM -5

    MDR report key: 2964571 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00699
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 30, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT CODE PROVIDED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    SURGEON WAS DOING A TOTAL HIP PROCEDURE USING THE SECURE FIT MAX STEM AND CUTTING EDGE INSTRUMENTS. SURGEON EXPERIENCED DIFFICULTY IN TRIALING WITH THE 36MM C-TAPER HEAD TRIALS. HE STATED THE TRIAL HEAD WILL NOT STAY IN PLACE AND COMES OFF TOO EASILY WHILE CONDUCTING RANGE OF MOTION. HE BELIEVES THIS CAUSED HIM TO SELECT AN INCORRECT HEAD OFFSET, WHICH HE HAD TO REMOVE AND CHANGE TO A DIFFERENT OFFSET DURING THE SURGERY ADDING A COUPLE OF MINUTES TO THE PROCEDURE. HE ALSO STATED WHEN THE TRIAL HEAD COMES OFF IT IS DIFFICULT TO RETRIEVE AND OR DISLOCATE THE HIP TO MAKE INTRA-OP CHANGES.

    Description of Event or Problem · 1

    SURGEON WAS DOING A TOTAL HIP PROCEDURE USING THE SECURE FIT MAX STEM AND CUTTING EDGE INSTRUMENTS. SURGEON EXPERIENCED DIFFICULTY IN TRIALING WITH THE 36MM C-TAPER HEAD TRIALS. HE STATED THE TRIAL HEAD WILL NOT STAY IN PLACE AND COMES OFF TOO EASILY WHILE CONDUCTING RANGE OF MOTION. HE BELIEVES THIS CAUSED HIM TO SELECT AN INCORRECT HEAD OFFSET, WHICH HE HAD TO REMOVE AND CHANGE TO A DIFFERENT OFFSET DURING THE SURGERY ADDING A COUPLE OF MINUTES TO THE PROCEDURE. HE ALSO STATED WHEN THE TRIAL HEAD COMES OFF IT IS DIFFICULT TO RETRIEVE AND OR DISLOCATE THE HIP TO MAKE INTRA-OP CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68104 C-TAPER TRIAL HEAD 36MM -5 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR