BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER METAGLENE

    MDR report key: 8821350 · Received July 24, 2019

    Report

    Report Number
    1818910-2019-99093
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, 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

    IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT WAS HAVING DISCOMFORT FOLLOWING REVERSE SHOULDER REPLACEMENT. HE SUSPECTED THE BASEPLATE TO BE LOOSE, HOWEVER IS WAS WELL FIXED. HE ELECTED TO REMOVE THE GLENOSPHERE AND METAGLENE AND CONVERTED THE STEM TO A CTA HEMI. PRODUCT NUMBERS FROM REMOVED IMPLANTS UNAVAILABLE. ORIGINAL IMPLANT DATE NOT AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614857 UNKNOWN SHOULDER METAGLENE SHOULDER METAGLENE KWS DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention