BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM

    MDR report key: 3233480 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02367
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT 5521-B600, LOT UNKNOWN, DESCRIPTION: TRI TS BASEPLATE SIZE 6;CAT 5550-L339, LOT UNKNOWN, DESCRIPTION: TRIAATHLON SYM PATELLA S33X9MM.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENTS' EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON X3 TS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT DETAILS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 5515-F-601, TRIATHLON PS FEM COMPONENT, CEMENTED, LOT CODE: UNKNOWN; CAT. NO.: 6191-1-001, SIMPLEX P FULL DOSE 1 PACK, LOT CODE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT KNEE BECAME INFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT KNEE BECAME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335146 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R