BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3013019 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01047
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    October 28, 2012
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION AND NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. FURTHERMORE, A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT OR STERILE LOT. REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOT. THE REPORTED EVENT IS NOT DEVICE 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. CAT. NO.: 5520-B-500, TRIATHLON PRIM CEM FXD BPLT #5, LOT CODE: S9K3B; CAT. NO.: 5515-F-602, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: GIRJA; CAT. NO.: 5550-G-339, TRIATHLON SYMMETRIC X3 PATELLA, LOT CODE: 17E0.

    Description of Event or Problem · 1

    PROSTHETIC JOINT INFECTION.

    Description of Event or Problem · 1

    PROSTHETIC JOINT INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115637 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLDW9A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention