BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL SOLID BK 52MM

    MDR report key: 3875327 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02310
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    November 26, 2007
    Report Date
    May 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND ELEVATED METAL LEVELS INVOLVING A TRIDENT HEMISPHERICAL SOLID BK 52MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, MEDICAL RECORDS, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL DEVICES HAVE BEEN REPORTED AT THIS TIME. DUE TO ONGOING LITIGATION, NO REQUESTS WILL BE MADE FOR ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE - LEGAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT HIP SURGERY USING TRIDENT ACETABULAR HIP SYSTEM ON (B)(6) 2007. IT IS ALLEGED THE PATIENT BEGAN TO EXPERIENCE EXTREME PAIN AND ELEVATED METAL LEVELS. THE PATIENT WAS REVISED ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT HIP SURGERY USING TRIDENT ACETABULAR HIP SYSTEM ON (B)(6), 2007. IT IS ALLEGED THE PATIENT BEGAN TO EXPERIENCE EXTREME PAIN AND ELEVATED METAL LEVELS. THE PATIENT WAS REVISED ON (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352953 TRIDENT HEMISPHERICAL SOLID BK 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 20961801

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R