BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #7

    MDR report key: 3002352 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00962
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT WHICH HAS AN EXPIRY DATE OF 10-2011 (OCTOBER 2011) INDICATED ON THE PACKAGING WAS REPORTEDLY USED IN SURGERY ON (B)(6) 2013. IT IS THE RESPONSIBILITY OF THE USER TO VERIFY THE EXPIRATION DATE AND ENSURE THAT THE PRODUCT IS USED WITHIN THIS TIME FRAME. IT IS REPORTED THAT THE SURGEON WAS INFORMED THAT THE PRODUCT WAS EXPIRED AND THE SURGEON DECIDED TO IMPLANT THE PRODUCT IN THE PATIENT ANYWAY. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE PROCEDURE, THE NURSE TOOK TWO ITEMS FROM A KNEE TRIATHLON KIT WHICH EXPIRY DATE WERE DUE. THE SURGEON WHO WAS ALREADY INFORMED OF THAT SITUATUION DECIDED TO IMPLANT THEM IN THE PATIENT.

    Description of Event or Problem · 1

    DURING A KNEE PROCEDURE, THE NURSE TOOK TWO ITEMS FROM A KNEE TRIATHLON KIT WHICH EXPIRY DATE WERE DUE. THE SURGEON WHO WAS ALREADY INFORMED OF THAT SITUATION DECIDED TO IMPLANT THEM IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105372 TRIATHLON PRIM CEM FXD BPLT #7 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SB7AX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other