BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON P/A CR BEADED #3L

    MDR report key: 2963733 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00688
    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
    MBH
    PMA / PMN Number
    K051380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PRESS-FITTING ISSUES INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED AS THE DEVICE REMAINS IMPLANTED. MEDICAL RECORDS REVIEW NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW INDICATED THAT THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR TOLERANCE AND COATING ANALYSIS. FURTHERMORE, USING BONE CEMENT WITH DEVICES SPECIFIED TO BE PRESS-FITTED IS AN OFF-LABEL APPLICATION. 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

    IT WAS REPORTED THAT THE FEMORAL COMPONENT DID NOT PRESS FIT WITH FEMUR. SO, THE FEMORAL COMPONENT CAME OFF FROM THE FEMUR WHEN THE TRIAL INSERT WAS INSERTED DURING TRIAL. THE SURGEON USED BONE CEMENT FOR THE FEMORAL COMPONENT. THE CUTTING DEVICE WHICH WAS USED IN THE OP WAS CAT# 6541-1-703E.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMORAL COMPONENT DID NOT PRESS FIT WITH FEMUR. SO, THE FEMORAL COMPONENT CAME OFF FROM THE FEMUR WHEN THE TRIAL INSERT WAS INSERTED DURING TRIAL. THE SURGEON USED BONE CEMENT FOR THE FEMORAL COMPONENT. THE CUTTING DEVICE WHICH WAS USED IN THE OP WAS CAT# 6541-1-703E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67538 TRIATHLON P/A CR BEADED #3L IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH EACTF

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other