BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 1900030 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01509
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE SURGEON AND RETURNED TO THE MFR. DOCTOR FELT IT WAS NOT NECESSARY TO RETURN, AS IT WAS DUE TO TRAUMA. ADD'L INFO INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR# 2249697-2010-01510.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT WAS IN A CAR ACCIDENT AND THE PATELLA WAS SHEARED OFF THE BONE. SURGEON REVISED WITH A ZIMMER SUTURE ON PATELLA AND ALSO SWAPPED OUT THE INSERT. THERE WAS A CRACK ON THE POST OF THE INSERT CAUSED BY THE TRAUMA, SO THIS WAS REVISED AS WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 125A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention