BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS TIBIAL INSERT TRIAL #2 - 11MM

    MDR report key: 3002686 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00979
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    K123166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED TRIATHLON STANDARD INSERT TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. A VISUAL INSPECTION CONFIRMS THE REPORTED FRACTURE. A DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE INVESTIGATION CONCLUDED THE REPORTED EVENT IS THE RESULT OF A DESIGN ISSUE. TO ADDRESS THIS ISSUE, A DESIGN CHANGE OCCURRED IN 2010 TO OBSOLETE THIS PRODUCT AND CREATE A NEW REPLACEMENT PRODUCT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #2 INSERT TRIAL BROKE DURING SURGERY. WENT TO IMPACT THE TRIAL AND IT CRACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #2 INSERT TRIAL BROKE DURING SURGERY. WENT TO IMPACT THE TRIAL AND IT CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104699 PS TIBIAL INSERT TRIAL #2 - 11MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH PPM1Z07

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other