BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER HUMERAL CUP

    MDR report key: 7364974 · Received March 23, 2018

    Report

    Report Number
    1818910-2018-55933
    Event Type
    Injury
    Date Received
    March 23, 2018
    Report Date
    March 13, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE OR PRODUCT DETAILS WERE RECEIVED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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.

    Description of Event or Problem · 1

    ARTICLE REVIEWED, "LONGITUDINAL OBSERVATIONAL STUDY OF REVERSE TOTAL SHOULDER ARTHROPLASTY FOR IRREPARABLE ROTATOR CUFF DYSFUNCTION: RESULTS AFTER 15 YEARS", BY CHRISTIAN GERBER, MD, ET AL., PUBLISHED IN J SHOULDER ELBOW SURG (2017). 52 CONSECUTIVE PATIENTS (23 MEN, 29 WOMEN) WITH AN IRREPARABLE ROTATOR CUFF TEAR AND SECONDARY PSEUDOPARALYSIS OF ACTIVE ANTERIOR ELEVATION WERE TREATED WITH THE DELTA III PROSTHESIS, (UTILIZING COMPETITOR CEMENT IF THE HUMERAL COMPONENT WAS CEMENTED). AT THE 15 YEAR FOLLOW-UP, 22 PATIENTS WERE ALIVE/AVAILABLE FOR EXAMINATION. ONE OR MORE POSTOPERATIVE COMPLICATIONS WERE RECORDED IN 13 PATIENTS. THIS COMPLAINT ADDRESSES A PATIENT WHO WAS SUBJECT TO LATE SHOULDER DISLOCATION, AT 64 MONTHS POST-IMPLANTATION, FOR WHICH THE TREATMENT WAS REVISION FOR POLYETHYLENE HUMERAL CUP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208502 UNKNOWN SHOULDER HUMERAL CUP SHOULDER HUMERAL CUP KWS DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention