BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON TIB INS STD SML 9MM

    MDR report key: 1698838 · Received May 21, 2010

    Report

    Report Number
    2249697-2010-00572
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 10, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORDS, COMPLAINT HISTORY AND CURRENT PACKAGING INSERT REVIEW. EVAL SUMMARY: AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MFR. BASED ON THE LIMITED INFO PROVIDED, THE RESULTS OF THE INVESTIGATION INDICATE THAT THERE ARE NO ISSUES FOR THE REPORTED DEVICES IN THIS EVENT. POLYETHYLENE WEAR ON TIBIAL INSERT AND PATELLA COMPONENTS IS EXPECTED, ESPECIALLY AFTER THEY WERE IMPLANTED FOR MORE THAN EIGHTEEN YEARS IN THE REPORTED EVENT. WITH ALL JOINT REPLACEMENTS, ASYMPTOMATIC, LOCALIZED, PROGRESSIVE BONE RESORPTION (OSTEOLYSIS) MAY OCCUR AROUND OR REMOTE FROM THE PROSTHETIC COMPONENTS AS A CONSEQUENCE OF FOREIGN BODY REACTION TO PARTICULATE MATTER. OSTEOLYSIS CAN LEAD TO FUTURE COMPLICATIONS NECESSITATING THE REMOVAL AND REPLACEMENT OF PROSTHETIC COMPONENTS. THE DEVICE HISTORY REVIEW FOR THE REPORTED LOT OF INSERTS INDICATES THAT DEVICES WERE MFG AND ACCEPTED INTO STOCK WITH NO REPORTED INCIDENTS. THE PRODUCT EXPERIENCE REPORTING DATABASE (2004 - PRESENT) SHOWS THAT THERE HAVE BEEN NO OTHER REPORTED EVENTS REGARDING CAT# 6630-1-109, LOT# TSSPA, AND ALL OTHER LOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISED DUE TO OSTEOLYSIS POLY WEAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON TIB INS STD SML 9MM IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA TSPPA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention