BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA SOLID BACK 56MM

    MDR report key: 2071011 · Received April 20, 2011

    Report

    Report Number
    9616680-2011-00233
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    August 20, 2002
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD HIS LEFT HIP REPLACEMENT ON (B)(6) 2002 AND STATED THAT EVER SINCE HIS SURGERY, HE HAS BEEN EXPERIENCING PAIN AND SWELLING. PT STATED THAT HE HAS SEEN SEVERAL SURGEONS AND THE SURGEONS NOTICED THAT HIS HIP WAS NOT SITTING IN IT CORRECT PLACE; HE ALSO STATED THAT HE WOULD NEED TO HAVE A REVISION SURGERY DONE. THE PT DEVELOPED A DVT, NERVE DAMAGE, AND IS CURRENTLY TAKING ANTI INFLAMMATORY AND TYLENOL FOR PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA SOLID BACK 56MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 79304601

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention