BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB MED 13

    MDR report key: 3961633 · Received July 28, 2014

    Report

    Report Number
    0002249697-2014-02875
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING INSTABILITY INVOLVING A DURA DURATION A/P TIB MED 13 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE DEVICE SHOWS SUBSURFACE DELAMINATION LEADING TO A RAISED PORTION IN THE ARTICULATING SURFACE. NO DISCREPANCIES OTHER THAN WEAR AFTER 15 YEARS WERE NOTED. MEDICAL RECORDS RECEIVED AND EVALUATION: REJECTED FOR MEDICAL REVIEW AS INSUFFICIENT INFORMATION WAS RECEIVED. DEVICE HISTORY REVIEW: INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE REPORTED EVENT INDICATES A REVISION OF THE INSERT AND PATELLA DUE TO LAXITY. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED ALTHOUGH IT IS LIKELY THAT THE RAISED ARTICULATING SURFACE DUE TO SUBSURFACE DELAMINATION CONTRIBUTED TO THE ¿POPPING¿ AND ¿PAIN¿ THAT THE PATIENT EXPERIENCED. THE DEVICE WAS IMPLANTED FOR APPROXIMATELY 15 YEARS WHICH COULD HAVE CONTRIBUTED TO THE INCREASED WEAR AND DELAMINATION. ADDITIONAL INFORMATION SUCH AS PATIENT HISTORY AND OPERATIVE NOTES ARE NEEDED TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LAXITY. SURGEON HAD IMPLANTED A (B)(4) PATELLA TRIATHLON X3 AND 6642-1-722 INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LAXITY. SURGEON HAD IMPLANTED A (B)(6) PATELLA TRIATHLON X3 AND 6642-1-722 INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439749 DURA DURATION A/P TIB MED 13 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH VUJWA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R