BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #4 PS INSERT 16MM

    MDR report key: 3102379 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01587
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 5550-L-298, TRIATHLON SYM PATELLA S29X8MM, LOT CODE: E410W. CAT. NO.: 5515-F-401, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: RSKAR. CAT. NO.: 5520-B-400, TRIATHLON PRIM TIB BASEPLATE - CEMENTED, LOT CODE: UHEL. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. NO DEVICE EVALUATION PERFORMED AS THE DEVICE WAS NOT RETURNED. A MEDICAL REVIEW WAS NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. THE INVESTIGATION CONCLUDED THAT THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS MANUFACTURING RELATED. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL. THE REPORTED EVENT REGARDING INFECTION INVOLVING A TRIATHLON TIBIAL INSERT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    AN INFECTION WAS REPORTED.

    Description of Event or Problem · 1

    AN INFECTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203920 TRIATHLON #4 PS INSERT 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH F911A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention