BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT LEFT TOTAL HIP

    MDR report key: 1032840 · Received April 22, 2008

    Report

    Report Number
    9616680-2008-00098
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PATIENT "HAD A TRIDENT LEFT TOTAL HIP REPLACEMENT IN 2003." IT IS FURTHER ALLEGED THAT, "TWO MONTHS LATER, SHE HAD A TRIDENT RIGHT TOTAL HIP REPLACEMENT." IT IS FURTHER ALLEGED THAT THE PATIENT, "REPORTED COMPLAINTS OF SQUEAKING IN BOTH HIPS TO HER PHYSICIAN IN 2005, CAUSING HER TO BE REVISED FOR BOTH THE LEFT AND RIGHT HIP IN 2006." THIS REPORT DOCUMENTS THE REVISION TO THE PATIENT'S LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT LEFT TOTAL HIP IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention