BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMC, TRAPEZIUM SIZE 20

    MDR report key: 7041100 · Received November 17, 2017

    Report

    Report Number
    0008031020-2017-00665
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 27, 2017
    Report Date
    March 27, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    KWG
    PMA / PMN Number
    P960053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DISPOSITION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT CMC, TRAPEZIUM SIZE 20 WAS ALLEGED OF 'ADDITIONAL/REVISION PROCEDURE' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE PATIENT RELATED. THE FAILURE WAS CAUSED BY TRAUMA. IT WAS REPORTED THIS REVISION SURGERY WAS SET UP DUE TO AN INJURY RELATED TO TRAUMA. THE IMPLANT HAS BEEN DESIGNED TO WITHSTAND KINEMATIC FORCES THAT REPRESENT NORMAL DAILY ACTIVITY. THERE ARE INSTANCES WHERE THE REMOVAL OF A DEVICE IS REQUIRED BECAUSE OF EXCESSIVE PHYSICAL ACTIVITY AND/OR ABUSE BY THE PATIENT CAUSED PERMANENT FUNCTIONAL DAMAGE TO THE DEVICE. THE PRODUCT INSERT AND SURGICAL TECHNIQUE DESCRIBE THE LIMITATIONS OF THIS DEVICE AS IT PERTAINS TO NORMAL PHYSICAL ACTIVITY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION OF RIGHT THUMB CMC ADVANTA ARTHROPLASTY AFTER DESCRIBING INJURY RELATED TO TRAUMA.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION OF RIGHT THUMB CMC ADVANTA ARTHROPLASTY AFTER DESCRIBING INJURY RELATED TO TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822602 CMC, TRAPEZIUM SIZE 20 FINGER JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS KWG STRYKER GMBH 24470401

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention