BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTISKNEE CUTTING GUIDE - STRYKER

    MDR report key: 1624844 · Received February 19, 2010

    Report

    Report Number
    3005738134-2010-00058
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    August 24, 2009
    Report Date
    February 10, 2010
    Manufacturer
    OTISMED CORPORATION
    Product Code
    OOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SEGMENTATION REVIEW, PLANNING REVIEW, JIG DESIGN REVIEW. RESULTS: SEGMENTATION REVIEW - PERFORMED SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. PLANNING REVIEW - PERFORMED TO SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. JIG DESIGN REVIEW - GUIDES MANUFACTURED TO SPECIFICATIONS USING CURRENT WORK INSTRUCTIONS. CONCLUSION - GUIDES ROTATED LATERALLY CUTTING OFF AN ADD'L 3MM POSTERIOR MEDIAL CONDYLE. PT HAD SIGNIFICANT WEAR ON THE LATERAL SIDE WITH LARGE OSTEOPHYTES. GUIDE LIKELY TIPPED AND ROTATED DUE TO DISEASE PROCESS AND PHYSICIAN ERROR.

    Description of Event or Problem · 1

    GUIDES FIT VERY WELL. DEEP POSTERIOR MEDIAL CUT. LATERAL POSTERIOR CUT WAS MEASURED AT 11MM AND MEDIAL POSTERIOR CUT WAS 14MM. KNEE WAS TIGHT LATERALLY AND LAX MEDIALLY. LATERAL CUT WAS REDONE TO MATCH MEDIAL AND THE PT IS OK, GOOD ROM AND STABLE IN FLEX AND EXTENSION. HAS 16MM LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTISKNEE CUTTING GUIDE - STRYKER NONE OOG OTISMED CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other