BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA SOLID BACK 52MM

    MDR report key: 1844628 · Received September 20, 2010

    Report

    Report Number
    9616680-2010-00583
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT CALLED TO REPORT THAT EVER SINCE THE SURGERY, SHE HAS BEEN EXPERIENCING PAIN, SOMETIMES EVEN WORSE THAN BEFORE THE SURGERY. DR. SAYS THAT HE IS NOT SEEING THE PROBLEM, THE POSITION LOOKS CORRECT. PT HAS HAD BACK SURGERY TO TRY AND CORRECT THE PROBLEM OF PAIN, BUT THE SEVERE PAIN REMAINS. SHE IS CURRENTLY UNABLE TO WORK, VERY DIFFICULT FUNCTIONING ON AN EVERYDAY LEVEL. PT IS ASKING IF ANY OF THESE IMPLANTS ARE PART OF ANY RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA SOLID BACK 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 88YMED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other