BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE ECC D38MM

    MDR report key: 8726865 · Received June 24, 2019

    Report

    Report Number
    1818910-2019-96616
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 4, 2019
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWS
    UDI-DI
    10603295027744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS WERE REMOVED TO TREAT THE INFECTION WITH A SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522967 DXTEND GLENOSPHERE ECC D38MM DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE KWS DEPUY FRANCE SAS - 3003895575 5321252 10603295027744

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention