BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTI ECCENTER-STERILE

    MDR report key: 2490910 · Received March 9, 2012

    Report

    Report Number
    1719045-2012-00155
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSD
    PMA / PMN Number
    K072578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DESIGN HISTORY FILE SHOWED THE FOLLOWING: THE COMPLAINT DESCRIBES THE MECHANISM OF FAILURE OF THE GLENOID. THE GLENOID FAILED BECAUSE THE PT WAS DOING PUSH-UPS TEN DAYS AFTER IMPLANTATION. BY PERFORMING THESE EXERCISES ONLY 10 DAYS AFTER TOTAL SHOULDER ARTHROPLASTY, THE PT WAS EXHIBITING NONCOMPLIANCE. IT IS WELL ESTABLISHED IN CLINICAL LITERATURE THAT LOADING OF THE SHOULDER JOINT SHOULD BE MINIMIZED FOR AN EXTENDED PERIOD OF TIME FOLLOWING SHOULDER ARTHROPLASTY. A REVIEW OF THE CLINICAL RISK ANALYSIS FOR THE EPOCA PROSTHESIS SHOWS THAT GLENOID LOOSENING RESULTING FROM PT NONCOMPLIANCE IS IDENTIFIED AS A RISK. THE DESIGN RISK ASSESSMENT AND RISK ANALYSIS OF THE DEVICE WAS REVIEWED AND ADEQUATELY ADDRESSES THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH EPOCA FOR A DEGENERATIVE SHOULDER ON AN UNK DATE. APPROXIMATELY 10 DAYS POSTOP, FOLLOW UP VISIT X-RAYS SHOWED THE GLENOID AS LOOSE. REPORTEDLY, PT WAS DOING PUSH UPS. DURING REVISION SURGERY ON (B)(6) 2012, THE GLENOID, HEAD AND ECCENTER WERE REMOVED WITHOUT ISSUE. WHILE REMOVING THE STEM, THE SET SCREW ON THE EXTRACTOR BROKEN AND SURGEON WAS UNABLE TO REMOVE THE STEM. THE STEM REMAINS IMPLANTED IN THE PT. ALL BROKEN PIECES WERE RETRIEVED. PT REVISED TO A COMPETITOR'S GLENOID AND SYNTHES ECCENTER AND HEAD. THE EXPLANTED GLENOID AND HEAD WAS DISCARDED BY THE HOSPITAL. THE STEM REMAINS IMPLANTED IN THE PT. THE ECCENTER WAS RETURNED FOR EVALUATION. THIS IS THE 3RD OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTI ECCENTER-STERILE ECCENTER HSD SYNTHES MONUMENT 6281089

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention GLENOID.| HEAD.| STEM.| HEAD| STEM| GLENOID