BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT CUP

    MDR report key: 2202456 · Received August 5, 2011

    Report

    Report Number
    9616680-2011-00526
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT WAS HEARING SQUEAKING, CLICKING AND WAS HAVING DISCOMFORT, SO THE SURGEON REVISED. SHE HAS BEEN CONTACTED BY A LEGAL FIRM IN NY TO HAVE HER CHECK WITH STRYKER AS TO WHETHER OR NOT HER IMPLANTS HAVE BEEN RECALLED. THE PT WAS RELUCTANT TO REVEAL ANY FURTHER INFO IN CASE IT IS TURNED OVER TO LEGAL COUNSEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIDENT CUP IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other