BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER LOCKING SCREW

    MDR report key: 7358766 · Received March 21, 2018

    Report

    Report Number
    1818910-2018-55782
    Event Type
    Injury
    Date Received
    March 21, 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). THIS REPORT PERTAINS TO FOUR INSTANCES OF THE SAME PRODUCT.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 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 WILL ADDRESS A PATIENT WHO EXPERIENCED A SCAPULA FRACTURE AT 3 MONTHS POST-IMPLANTATION, TREATED SURGICALLY WITH OPEN REDUCTION INTERNAL FIXATION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ABOUT THIS FRACTURE, REGARDING CAUSE, LOCATION ON THE SCAPULA, OR SPECIFICS OF THE ORIF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201395 UNKNOWN SHOULDER LOCKING SCREW SHOULDER LOCKING SCREW KWS DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention