BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CONSTRAINED INSERT

    MDR report key: 4863423 · Received June 23, 2015

    Report

    Report Number
    0002249697-2015-02037
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    March 12, 2014
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    P960047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND MATERIAL ANALYSIS OF THE RETURNED DEVICE REVEALED AN INDENTATION ON THE ARTICULATING SURFACE OF THE UNIVERSAL HEAD. THE MATERIAL ANALYSIS REPORT CONCLUDED EDS WAS PERFORMED ON THE UNIVERSAL HEAD AND THE FEMORAL HEAD BASE MATERIALS, AND THEY WERE BOTH CONSISTENT WITH DRAWING REQUIREMENTS. EDS WAS ALSO PERFORMED ON THE SCRATCH ON THE UNIVERSAL HEAD, AND WAS CONSISTENT WITH BIOLOGICAL DEBRIS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED THAT THIS EVENT IS NOT DEVICE-RELATED AND LIKELY CAUSED BY AN ADVERSE MIX OF PATIENT-RELATED AND PROCEDURE-RELATED FACTORS THAT CANNOT BE FURTHER DETAILED DUE TO LACK OF SPECIFIC INFORMATION. CUP MALPOSITION IN LOW INCLINATION AND LOW ANTEVERSION HAS QUITE LIKELY CONTRIBUTED TO THE PATIENT¿S PAIN PROBLEM LEADING TO REVISION SURGERY. THE OBSERVED SCRATCHES ON THE SURFACE OF THE UNIVERSAL HEAD QUITE EVIDENTLY HAVE CAUSED THE NOISE GENERATION IN THE ARTHROPLASTY ALTHOUGH THE UNDERLYING CAUSE FOR THE SCRATCHES CANNOT BE DETERMINED DUE TO LACK OF INFORMATION. THE DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THERE HAS BEEN NO SIMILAR EVENTS FOR THE REPORTED LOT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FIRST SURGERY WAS SUCCESSFULLY PERFORMED, BUT THE PATIENT FELT DISCOMFORT AND NOISE WHEN WALKING. A SECOND SURGERY WAS PERFORMED SUCCESSFULLY TO REPLACE CUP, INSERT AND HEAD.

    Description of Event or Problem · 1

    THE FIRST SURGERY WAS SUCCESSFULLY PERFORMED, BUT THE PATIENT FELT DISCOMFORT AND NOISE WHEN WALKING. A SECOND SURGERY WAS PERFORMED SUCCESSFULLY TO REPLACE CUP, INSERT AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405402 TRIDENT CONSTRAINED INSERT IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MML2W4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R