BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SHOULDER HUMERAL STEMS

    MDR report key: 8004372 · Received October 25, 2018

    Report

    Report Number
    1818910-2018-73496
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Report Date
    October 3, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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. 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. CONCOMITANT MED PRODUCTS: UNKNOWN SHOULDER HUMERAL CUP COMPONENT; UNKNOWN SHOULDER HUMERAL STEM COMPONENT; UNKNOWN SHOULDER HUMERAL PROXIMAL BODY COMPONENT; UNKNOWN SHOULDER GLENOSPHERE COMPONENT; UNKNOWN SHOULDER METAGLENE COMPONENT; UNKNOWN SHOULDER METAGLENE LOCKING SCREW COMPONENTS X 4 (B)(4).

    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 DEEP INFECTION OF THE HUMERAL COMPONENT, RESULTING IN SEPTIC LOOSENING OF THE IMPLANT, AT 110 MONTHS POST-IMPLANTATION. THIS WAS TREATED WITH HUMERAL COMPONENT AND POLYETHYLENE CUP LINER EXCHANGES. IT WAS NOT INDICATED WHETHER THE HUMERAL COMPONENT WAS A CEMENTED PRODUCT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843980 UNKNOWN SHOULDER HUMERAL STEMS SHOULDER HUMERAL STEMS KWS DEPUY ORTHOPAEDICS, INC. 1818910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention