BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI 2MM OFFSET ADAPTER TRIAL

    MDR report key: 2963757 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00693
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. VISUAL INSPECTION: CATALOG NUMBER, LOT ID AND CE MARK ARE FADED FROM STERILIZATION. CONNECT PORTION OF THE DEVICE IS WORN FROM USE. NO VISUAL DISCREPANCIES ARE NOTED. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE DEVICE WAS CONFIRMED TO BE FULLY FUNCTIONAL. FUNCTIONAL INSPECTION: A TRIATHLON TS FEMORAL TRIAL, CATALOG: 5512-T-401 LOT: MDKT, AND A METAL STEM TRIAL, CATALOG: 5565-T-019A LOT: RD9T020, WERE RETRIEVED FROM FINISHED GOODS FOR THE PURPOSE OF THE FUNCTIONAL INSPECTION OF THE SUBJECT OFFSET TRIAL. THE INSTRUMENTS WERE ASSEMBLED WITHOUT DIFFICULTY. THE EVENT COULD NOT BE CONFIRMED AND THE RETURNED OFFSET TRIAL WAS VERIFIED TO BE FULLY FUNCTIONAL. THE INVESTIGATION CONCLUDED THAT THE SURGICAL PROTOCOL WAS NOT FOLLOWED AS THE SURGEON DID NOT USE THE INSTRUMENT INTENDED TO DISASSEMBLE THE OFFSET ADAPTOR TRIAL FROM THE FEMORAL TRIAL BOSS. FUNCTIONAL INSPECTION COULD NOT CONFIRM THE REPORTED FUNCTIONAL ISSUES. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A TRIATHLON TS WAS TRIALING THE FEMORAL STEM AND IT DID NOT SEAT COMPLETELY, SOMETHING CAUSING IT TO HANG UP. USED THE SLAP HAMMER REMOVED PROSTHESIS THE FEMORAL TRIAL COMPONENT DETACHED FROM THE OFFSET. LEFT WITH OFFSET AND FEMORAL STEM AND PATIENTS FEMORAL CANAL. PUT FEMUR BACK ON AND DID ATTACH, TRIED TO REMOVE AGAIN AND SAME THING HAPPENED. USED HAMMER TO REMOVE AGAIN AND CAME OFF. WENT DOWN ONE DIAMETER TO 18 STEM TRIAL AND WORKED FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS DOING A TRIATHLON TS WAS TRIALING THE FEMORAL STEM AND IT DID NOT SEAT COMPLETELY, SOMETHING CAUSING IT TO HANG UP. USED THE SLAP HAMMER REMOVED PROSTHESIS THE FEMORAL TRIAL COMPONENT DETACHED FROM THE OFFSET. LEFT WITH OFFSET AND FEMORAL STEM AND PATIENTS FEMORAL CANAL. PUT FEMUR BACK ON AND DID ATTACH, TRIED TO REMOVE AGAIN AND SAME THING HAPPENED. USED HAMMER TO REMOVE AGAIN AND CAME OFF. WENT DOWN ONE DIAMETER TO 18 STEM TRIAL AND WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66683 TRI 2MM OFFSET ADAPTER TRIAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P5E11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other