BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ACETABULAR SYSTEM

    MDR report key: 2062554 · Received April 7, 2011

    Report

    Report Number
    9616680-2011-00183
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    September 19, 2006
    Report Date
    March 18, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PT REC'D A TRIDENT ACETABULAR HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PT IS EXPERIENCING "LOOSENING" FROM THE SYSTEM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention