BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER GLENOSPHERE

    MDR report key: 9007641 · Received September 12, 2019

    Report

    Report Number
    1818910-2019-104120
    Event Type
    Injury
    Date Received
    September 12, 2019
    Report Date
    August 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    LITERATURE ARTICLE ENTITLED: ¿LITERATURE RECEIVED ENTITLED: "ATRAUMATIC BILATERAL SCAPULAR SPINE FRACTURE SEVERAL MONTHS AFTER BILATERAL REVERSE TOTAL SHOULDER ARTHROPLASTY" WRITTEN BY SIMON NICOLAY ET AL., PUBLISHED ONLINE: 26 NOVEMBER 2013, DOI 10.1007/S00256-013-1775-4, WAS REVIEWED FOR MDR REPORTABILITY ON 08/20/2019. THE ARTICLE REPORTS THAT AN (B)(6) YEAR OLD WOMAN WITH A HISTORY OF PAIN, GLENOHUMERAL OSTEOARTHRITIS, AND FUNCTIONAL LOSS IN BOTH SHOULDERS. THE PATIENT RECEIVED A DELTA X-TEND REVERSED RIGHT TOTAL SHOULDER PROSTHESIS TO ADDRESS PAIN, GLENOHUMERAL OSTEOARTHRITIS AND FUNCTION LOSS. RADIOGRAPHS OF THE SHOULDER ONE WEEK OUT WERE REPORTED TO SHOW NO ABNORMALITIES. FIVE MONTHS AFTER DOI OF RIGHT SHOULDER, RADIOGRAPHS WERE REPORTED TO SHOW A RIGHT SCAPULAR SPINE FRACTURE. NO REVISION WAS PERFORMED. THE PAIN EVENTUALLY WAS REPORTED TO HAVE SUBSIDED, BUT THE PATIENT STILL HAD FUNCTIONAL LOSS RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802301 UNKNOWN SHOULDER GLENOSPHERE SHOULDER HUMERAL HEADS KWS DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention