BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3123630 · Received May 22, 2013

    Report

    Report Number
    0002249697-2013-01742
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE MUST GO TO PATHOLOGY AND HOSPITAL WILL NOT RELEASE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    PATIENT FELL WHILE WALKING. HEMATOMA AND TORE RETINACULUM. DOCTOR CLEANED OUT AREA OF PATELLA AND REPAIRED. NEEDED TO EXCHANGE POLY TO REPAIR KNEE.

    Description of Event or Problem · 1

    PATIENT FELL WHILE WALKING. HEMATOMA AND TORE RETINACULUM. DOCTOR CLEANED OUT AREA OF PATELLA AND REPAIRED. NEEDED TO EXCHANGE POLY TO REPAIR KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226212 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMAHEA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention