BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 4MM

    MDR report key: 2003077 · Received February 8, 2011

    Report

    Report Number
    2249697-2011-00135
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT#: M5C08AE, EXPIRATION DATE: 06/29/2015, STERILE LOT # MSHJK30A3, DEVICE MANUFACTURE DATE: 06/29/2010. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. (B)(6) REPORTS VIA OUR SALES REP, (B)(6), THAT IT WAS NOT POSSIBLE TO USE THE OFFSET ADAPTERS OUT OF THE LOANER SYS AS IT WAS NOT POSSIBLE TO SCREW THEM IN. DR. K. REPORTS FURTHER THAT HE USED A SCORPIO TS ADAPTER WHICH WAS ON STOCK IN THE HOSPITAL INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 4MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA M5C08AX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other