BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 2220609 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01063
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS IMPLANTED. IF ADDITIONAL INFORMATION IS PROVIDED, THE EVALUATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "UPON OPENING THE PSL SHELL, THE SURGERY TECH AND DOCTOR NOTICED A FIBER TYPE MATERIAL ON THE EDGE OF THE SHELL. IT WASN'T KNOWN WHAT THE MATERIAL WAS OR IF THE FIBER WAS IN THE PACKAGE OR GOT ON SUBSEQUENT TO OPENING. AFTER DISCUSSION AND GOING THROUGH OTHER SHELL OPTIONS, SURGEON DECIDED TO SANITIZE THE SAME SHELL WITH A BETADINE FLUID AND REMOVE THE FIBER. HE PROCEEDED TO PUT THE SHELL IN THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJN596

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other