BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO SUPERFLEX CR TIBIAL

    MDR report key: 3910320 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02497
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INSTABILITY INVOLVING A SCORPIO SUPERFLEX CR TIBIAL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A MATERIAL ANALYSIS INDICATED ASYMMETRICAL WEAR WHICH MAY INDICATE MISALIGNMENT OR INSTABILITY. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE RETURNED ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE TIBIAL INSERTS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. WHILE THE MATERIAL ANALYSIS REPORT IDENTIFIED ASYMMETRICAL WEAR WHICH MAY INDICATE MISALIGNMENT OR INSTABILITY FURTHER INFORMATION IS NEEDED TO DETERMINE THE ROOT CAUSE OF THE INSTABILITY. FURTHER INFORMATION SUCH AS PATIENT MEDICAL RECORDS AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE OF THE REPORTED INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTS WHICH WERE IMPLANTED FOR BOTH KNEES AND REPLACED 12 YEARS AFTER IMPLANTED. SOFT TISSUE LOOSENING WAS CONFIRMED, SO THEY (8MM) WERE CHANGED TO 15MM INSERTS. NUMBER 3 WAS RIGHT SIDE, AND #5 WAS LEFT SIDE. THE SURGEON REQUESTS US TO CONDUCT THE ABRASION MEASUREMENT. THE AMOUNT OF THE ABRASION IS PROPER OR NOT PROPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERTS WHICH WERE IMPLANTED FOR BOTH KNEES AND REPLACED 12 YEARS AFTER IMPLANTED. SOFT TISSUE LOOSENING WAS CONFIRMED, SO THEY (8MM) WERE CHANGED TO 15MM INSERTS. #3 WAS RIGHT SIDE, AND #5 WAS LEFT SIDE. THE SURGEON REQUESTS US TO CONDUCT THE ABRASION MEASUREMENT. THE AMOUNT OF THE ABRASION IS PROPER OR NOT PROPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386891 SCORPIO SUPERFLEX CR TIBIAL IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R