BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURACON POSTERIOR STABILIZED INSERT

    MDR report key: 1502339 · Received October 7, 2009

    Report

    Report Number
    2249697-2009-00693
    Event Type
    Injury
    Date Received
    October 7, 2009
    Date of Event
    August 31, 2009
    Report Date
    September 11, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS REPORT WAS GENERATED BASED ON AN ARTICLE, NO DEVICE OR ADDITIONAL INFO IS AVAILABLE. IT IS NOT KNOWN WHETHER THESE EVENTS WERE PREVIOUSLY REPORTED TO STRYKER AS THE DEVICE, PT AND HOSPITAL INFO IS UNK. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED IN AN ARTICLE ("MIGRATION OF POLYETHYLENE FIXATION SCREW AFTER TOTAL KNEE ARTHROPLASTY" JOA, 08/2009, VOLUME 24, NUMBER 5). DURACON POSTERIOR STABILIZED TOTAL KNEE SYSTEM HAS A SNAP FIT LOCKING MECHANISM OF A TIBIAL POLYETHYLENE, INCLUDING AN ADDITIONAL LOCKING SCREW FOR FURTHER FIXATION OF POLYETHYLENE. WE REPORT CASES OF LOCKING SCREW MIGRATION FROM TIBIAL COMPONENT AFTER DURACON POSTERIOR STABILIZED PRIMARY TOTAL KNEE ARTHROPLASTY. SCREW MIGRATION IN SOME ASYMPTOMATIC CASES WAS INCIDENTALLY DETECTED DURING REGULAR FOLLOW-UP, AND THEY WERE JUST OBSERVED IN THE OUTPATIENT CLINIC. SOME HAD MODERATE PAIN, SWELLING, AND INSTABILITY, AND REVISION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DURACON POSTERIOR STABILIZED INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention