BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER GLENOID

    MDR report key: 9336605 · Received November 18, 2019

    Report

    Report Number
    1818910-2019-114315
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    January 1, 2013
    Report Date
    October 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: CORRECTED:H6(DEVICE CODES) . PRODUCT COMPLAINT(B)(4). INVESTIGATION SUMMARY : NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED ¿HEMIARTHROPLASTY VS TOTAL SHOULDER REPLACEMENT FOR ROTATOR CUFF INTACT OSTEOARTHRITIS: HOW TO THEY FARE AFTER A DECADE?¿ BY MICHAEL J. SANDOW, BMBS, FRACS; HUW DAVID, MBMCHR, FRCS, MCS (ORTH); AND STEVEN J. BENTALL, FRACS; PUBLISHED IN THE JOURNAL OF SHOULDER AND ELBOW SURGERY, VOLUME 22, 877-885, 2013, WAS REVIEWED. THE INITIAL AIM OF THE STUDY WAS TO COMPARE THE SHORT-TERM EFFICACY OF HA AND TSR IN PATIENTS WITH OSTEOARTHRITIS AND AN INTACT ROTATOR CUFF; HOWEVER, IN VIEW OF THE ONGOING CONTROVERSY, PATIENTS WERE PROGRESSIVELY REVIEWED AFTER THE INITIAL STUDY PERIOD TO PROVIDE A COMPARISON OF THE SAME STUDY GROUPS IN THE LONGER TERM. THE GLOBAL SHOULDER ARTHROPLASTY SYSTEM (DEPUY) WAS USED WITH INTRAOPERATIVE RANDOMIZATION AFTER GLENOID EXPOSURE. PATIENTS WERE INITIALLY ASSESSED WITH REGARDS TO THEIR OUTCOMES AT 2 YEARS AND PROSPECTIVELY MONITORED FOR 10 YEARS. 33 PATIENTS -13 HA AND 20 TSR- WERE INTRAOPERATIVELY RANDOMIZED TO HA OR TSR USING THE RANDOMIZATION METHOD. PATIENTS IN THE STUDY GROUPS WERE UNEVENLY DISTRIBUTED BECAUSE THE INSTITUTIONAL REVIEW BOARD SUSPENDED THE TRIAL BEFORE COMPLETION OF PATIENT RECRUITMENT TO THE NUMBER SPECIFIED IN THE PREDETERMINED SAMPLE SIZE CALCULATION. THE ARTICLE REPORTS: 1) ONE HA PATIENT HAD UNDERGONE REVISION TWO YEARS POSTOPERATIVELY DUE TO SEVERE PAIN SECONDARY TO GLENOID EROSION 2) THREE FURTHER HA PATIENTS WERE SUBSEQUENTLY REVISED, TWO AT THREE YEARS, AND ONE AT FOUR YEARS 3) TWO SHOULDERS IN THE TSR GROUP WERE REVISED AT FIVE YEARS AND SEVEN YEARS DUE TO PAIN SECONDARY TO GLENOID COMPONENT LOOSENING 4) IN ALL OF THE REVISED HA PATIENTS, THERE WAS SIGNIFICANT EROSION OF THE GLENOID THAT MADE THE CONVERSION TO TSR MORE CHALLENGING 5) ONE TSR PATIENT REQUIRED REVISION OF THE HUMERAL COMPONENT ALIGNMENT WITHIN ONE WEEK DUE TO MALPOSITION AND INCORRECT VERSION OF THE HUMERAL PROSTHESIS. OWING TO THE ISSUE OF THE SURGEON¿S TECHNICAL ERROR AND THE NEED FOR PERIOPERATIVE MANAGEMENT, THIS WAS REGARDED AS A COMPLICATION RATHER THAN AS FULFILLING THE CRITERIA OF PROTHESIS REVISION FOR PAIN, LOOSENING OR INFECTION. 6) ADDITIONALLY, TWO HA PATIENTS REQUIRED EARLY REVISION AND TWO FURTHER PATIENTS WERE EXPERIENCING A DETERIORATION OF THEIR PAIN LEVELS. ALL TSR¿S WERE PERFORMED USING HYLAMER (DEPUY) WHICH HAS BEEN REPORTED TO HAVE A HIGHER FAILURE RATE THAT STANDARD POLYETHYLENE. THIS ISSUE MAY HAVE SKEWED THE RESULTS AGAINST TSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130626 UNKNOWN SHOULDER GLENOID UNKNOWN SHOULDER GLENOID KWS DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention