BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO CR TIB INSERT

    MDR report key: 3181331 · Received June 21, 2013

    Report

    Report Number
    0002249697-2013-02009
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Adverse Event
    Yes
    Product Problem
    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

    AN EVENT REGARDING WEAR INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS. A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "ROOT CAUSE FOR FAILURE IN THIS CASE IS THE PRESENCE OF BOTH VARUS MALALIGNMENT IN THE KNEE AS WELL AS CLEAR EVIDENCE FOR THE PRESENCE OF INSTABILITY IN THE ARTHROPLASTY JOINT. RADIOLOGICAL FINDINGS SUPPORT THE CONCLUSION OF THE MAR THAT MALALIGNMENT AND/OR INSTABILITY ARE AT THE ROOT CAUSE OF PROBLEMS AS OBSERVED. BECAUSE BOTH ADEQUATE SURGICAL PREPARATION OF THE BONE AS WELL AS PRESERVATION OF JOINT STABILITY BY CHOICE OF OPTIMAL LINER TYPE AND THICKNESS ARE THE RESPONSIBILITY OF THE SURGEON, THE ROOT CAUSE FOR FAILURE IS PROCEDURE-RELATED. THERE IS NO EVIDENCE FOR FURTHER PATIENT-RELATED OR DEVICE-RELATED FACTORS ADDING TO THIS SCENARIO. AS SUCH, THIS PI CASE IS NOT-DEVICE-RELATED." A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. A MATERIAL ANALYSIS WAS PERFORMED, NO MATERIAL OR MANUFACTURING DEFECTS WERE IDENTIFIED. THE ROOT CAUSE OF THE WEAR WAS DETERMINED TO BE AS A RESULT OF PROCEDURAL FACTORS. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WAS REPLACED DUE TO THE ABRASION. THE ABRASION OF LATERAL MEDIAL AREA OF THE INSERT WAS SEVERELY DAMAGED. THE SURGEON THINKS THAT THE CAUSE OF THE SEVERE DAMAGE IS THAT FEMORAL AND TIBIAL COMPONENT HIT EACH OTHER. SLIGHT DEGREE OF THE METALLOSIS WAS CONFIRMED, BUT THERE WAS NO DAMAGE OF THE FEMORAL AND THE TIBIAL COMPONENT. SO, ONLY THE INSERT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WAS REPLACED DUE TO THE ABRASION. THE ABRASION OF LATERAL MEDIAL AREA OF THE INSERT WAS SEVERELY DAMAGED. THE SURGEON THINKS THAT THE CAUSE OF THE SEVERE DAMAGE IS THAT FEMORAL AND TIBIAL COMPONENT HIT EACH OTHER. SLIGHT DEGREE OF THE METALLOSIS WAS CONFIRMED, BUT THERE WAS NO DAMAGE OF THE FEMORAL AND THE TIBIAL COMPONENT. SO, ONLY THE INSERT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283423 SCORPIO CR TIB INSERT IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH 571201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R