BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER HUMERAL CUP

    MDR report key: 7378588 · Received March 28, 2018

    Report

    Report Number
    1818910-2018-56324
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 28, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #:(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    ARTICLE REVIEWED ENTITLED: "THE REVERSE SHOULDER: PROMISES AND PITFALLS", BY CARL J. BASAMANIA, MD, PUBLISHED IN SEMINARS IN ARTHROPLASTY (SEMIN ARTHRO 15:176-182 2005). AUTHOR PROVIDES SURGICAL TECHNIQUE AND POTENTIAL ISSUES EXPERIENCED IN THE USE OF THE DEPUY DELTA III REVERSE SHOULDER PROSTHESES. THERE WERE TWO REPORTED COMPLICATIONS: AN EPISODE OF SCAPULAR NOTCHING THAT LED TO A FRANK FRACTURE OF THE GLENOID-SCAPULAR NECK; AND AN EPISODE OF SHOULDER DISLOCATION REQUIRING REVISION TO ADD AN ADDITIONAL HUMERAL SPACER TO "TIGHTEN" THE JOINT. THESE ADVERSE EVENTS WILL BE ADDRESSED SEPARATELY IN TWO COMPLAINTS. THIS COMPLAINT WILL ADDRESS THE REPORTED SHOULDER DISLOCATION THAT OCCURRED ONE WEEK POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222612 UNKNOWN SHOULDER HUMERAL CUP SHOULDER HUMERAL CUP KWS DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention