BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT ACETABULAR SYSTEM

    MDR report key: 2202452 · Received August 5, 2011

    Report

    Report Number
    9616680-2011-00520
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY, "THE PT RECEIVED A TRIDENT ACETABULAR SYSTEM." IT WAS FURTHER ALLEGED THAT, "THE PT IS EXPERIENCING UNK INJURIES AND DAMAGES FROM THE SYSTEM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other