BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI HUMERAL STEM PRESS-FIT SIZE 10/125MM-STERILE

    MDR report key: 2782168 · Received October 4, 2012

    Report

    Report Number
    1719045-2012-01013
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSD
    PMA / PMN Number
    K072578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH EPOCA SHOULDER PROSTHESIS SYSTEM ON (B)(6) 2012 FOR A FOUR PART PROXIMAL HUMERUS FRACTURE. PATIENT HAD AN ANTERIOR DISLOCATION DUE TO ROTATOR CUFF DEFICIENCY WHICH WAS CONFIRMED BY EXAMINATION AND X-RAYS. SURGEON SUSPECTED THE PATIENT MAY NOT HEAL, THE TUBEROSITIES DUE TO THE AMOUNT OF BONE THAT WAS LEFT FROM THE PATIENT'S ORIGINAL INJURY. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO NON-UNION OF TUBEROSITY. PATIENT WAS REVISED TO A HEMIARTHROPLASTY OF SHOULDER WITH DEPUY CTA HEAD AND A GLOBAL FRACTURE STEM DUE TO THE DEFICIENCY OF THE TUBEROSITIES. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI HUMERAL STEM PRESS-FIT SIZE 10/125MM-STERILE TI HUMERAL STEM PRESS-FIT HSD SYNTHES MONUMENT 6746603

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HEAD| ECCENTER