BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER METAGLENE

    MDR report key: 9008436 · Received September 12, 2019

    Report

    Report Number
    1818910-2019-104068
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    July 1, 2006
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. 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

    "ARTICLE RECEIVED ENTITLED: "ACROMIAL BASE FRACTURES AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY: REPORT OF FIVE CASES", TREVOR C. WAHLQUIST, MS, ET. AL, PUBLISHED IN J SHOULDER ELBOW SURG (2011) 20, 1178-1183. AUTHORS EXAMINED THE TREATMENTS AND RESULTS OF FIVE PATIENTS WHO EXPERIENCED ACROMIAL BASE FRACTURES FOLLOWING REVERSE TOTAL SHOULDER ARTHROPLASTY. OF THE FIVE, THREE PATIENTS WERE REPORTED TO HAVE BEEN IMPLANTED WITH DEPUY REVERSE TOTAL SHOULDER ARTHROPLASTY DEVICES. THE STUDY BROKE THESE CASES DOWN INTO THE FIVE INDIVIDUAL PATIENTS. SPECIFIC PRODUCT AND LOT CODE INFORMATION WAS NOT PROVIDED FOR THE DEVICES, NOR WERE SPECIFIC DATES OF EVENTS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809418 UNKNOWN SHOULDER METAGLENE SHOULDER METAGLENE HSD DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention