BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON TIB INS STD SML 11MM

    MDR report key: 3023946 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01131
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2010
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH CONFIRMS THE REPORTED WEAR ON THE ARTICULATING SURFACE. DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. ALTHOUGH THE EVENT WAS CONFIRMED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO PATIENT MEDICAL RECORDS WERE RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO POLYETHYLENE WEAR. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROX 17.25 YEARS. THE TIBIAL POLYETHYLENE INSERT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 4 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 6.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO POLYETHYLENE WEAR. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~17.25 Y. THE TIBIAL POLYETHYLENE INSERT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 4 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126206 DURACON TIB INS STD SML 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH TYSKA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention