BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB SM 11

    MDR report key: 6118379 · Received November 21, 2016

    Report

    Report Number
    0002249697-2016-03721
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    January 25, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING A DURACON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED FROM THE IMAGES PROVIDED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES OF THE EXPLANTED DEVICE WERE RECEIVED. THE IMAGES SHOWED LARGE AMOUNTS OF WEAR ON THE INSERT.. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    REVISION OF RIGHT KNEE DUE TO PAIN & INSTABILITY. AFTER EXPLANTING POLYETHYLENE DISPLAYED EXCESSIVE WEAR POSTERIORLY.

    Description of Event or Problem · 1

    REVISION OF RIGHT KNEE DUE TO PAIN & INSTABILITY. AFTER EXPLANTING POLYETHYLENE DISPLAYED EXCESSIVE WEAR POSTERIORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767258 DURA DURATION A/P TIB SM 11 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 09445401

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R