BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT -

    MDR report key: 2850381 · Received November 16, 2012

    Report

    Report Number
    3005738134-2012-00037
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS ALAMEDA
    Product Code
    MBH
    PMA / PMN Number
    K110533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE SURGEON AND WAS NOT RETURNED TO THE MFR. ADD'L INCLUDING X-RAYS AND MEDICAL RECORDS WAS NOT MADE AVAILABLE EITHER. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, INITIAL TIBIAL IMPLANT HAD EXCESSIVE POSTERIOR SLOPE. SIXTEEN DEGREES OF POSTERIOR SLOPE AND 5 DEGREES OF VALGUS ACCORDING TO THE NAVIGATION DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - INSTRUMENT MBH STRYKER ORTHOPAEDICS ALAMEDA NA 12165041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention