BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 28MM ID

    MDR report key: 3172737 · Received June 17, 2013

    Report

    Report Number
    0002249697-2013-01927
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIDENT LINER 10' 28MM E POLY. ADDITIONAL DEVICES LISTED IN THIS REPORT: UNKNOWN ACETABULAR DOME HOLE PLUG; UNKNOWN 28MM CERAMIC C-TAPER HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE HOSPITAL. AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. IN THIS CASE ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS, REPORTED AS UNKNOWN IN INITIAL MDR, HAVE BEEN IDENTIFIED AS FOLLOWS: CATALOG #: 2060-0000-1; LOT #: MER0VX; MFR DATE: 11/06/2008; EXP. DATE: 11/30/2013; ACETABULAR DOME HOLE PLUG. CATALOG #: 18-28-3; LOT #: 14198601; MFR DATE: 06/27/2005; EXP. DATE: 06/30/2010; DELTA C-TAPER HEAD 28MM -2.5.

    Description of Event or Problem · 1

    EXPLORATION OF HIP CAPSULE DUE TO ILLIOSOAS TENDINITIS ROUTINE REVISION OF REVISION OF LINER, DOME HOLE PLUG AND CERAMIC FEMORAL HEAD.

    Description of Event or Problem · 1

    EXPLORATION OF HIP CAPSULE DUE TO ILIOPSOAS TENDINITIS ROUTINE REVISION OF REVISION OF LINER, DOME HOLE PLUG AND CERAMIC FEMORAL HEAD.

    Description of Event or Problem · 1

    EXPLORATION OF HIP CAPSULE DUE TO ILIOPSOAS TENDINITIS ROUTINE REVISION OF REVISION OF LINER, DOME HOLE PLUG AND CERAMIC FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274428 TRIDENT 10° X3 INSERT 28MM ID IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 25436801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention