BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3925579 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02605
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 27, 2006
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    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 DUE TO ONGOING LITIGATION. LOT NUMBERS 6391302 AND 16621604 WERE NOTED IN THIS REPORT BUT IT IS NOT CLEAR WHICH, IF EITHER OF THESE LOTS, WERE INVOLVED WITH THE PATIENT'S REVISION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE - LEGAL CASE.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS STILL UNKNOWN. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DEVICE DEGENERATION INVOLVING A TRDENT ALUMINA LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW NOT PERFORMED AS A REASON FOR REVISION WAS NOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    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 CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6), 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6), 2013.

    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 CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6) 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013.

    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 CERAMIC ON CERAMIC HIP SYSTEM ON (B)(6) 2006. IT IS ALLEGED "HER PROSTHETICS HAD DEGENERATED". THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404024 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R