BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON

    MDR report key: 1853239 · Received September 30, 2010

    Report

    Report Number
    1644408-2010-00508
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 5.1 MONTHS OF PT USE. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NON-CONFORMING MATERIAL REPORT # (B)(4) ASSOCIATED WITH THIS PRODUCT THAT DID NOT AFFECT IMPLANT SAFETY OR EFFECTIVENESS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN INSTABILITY; SUCH AS ROTATOR CUFF FAILURE. AS REPORTED, THE PT'S ROTATOR CUFF FAILED AND THIS REVISION WAS TO CONVERT THE PT TO AN RSP SYSTEM TO HELP RESTORE FUNCTIONALITY OF THE JOINT. THIS IS A NORMAL PROGRESSION OF JOINT SYSTEMS FOR THE SYSTEM OF ROTATOR CUFF FAILURE, NO FAILURE OF THE ORIGINAL IMPLANTS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO PT'S ANATOMY THE ROTATOR CUP FAILED REQUIRING PT TO BE CONVERTED TO A REVERSE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON HUMERAL STEM HSD ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention