BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COMPREHENSIVE HEMI-ARTHROPLASTY STEM

    MDR report key: 6762995 · Received August 3, 2017

    Report

    Report Number
    0001825034-2017-05602
    Event Type
    Death
    Date Received
    August 3, 2017
    Date of Event
    February 4, 2016
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: UNKNOWN COMPREHENSIVE TAPER, CATALOG#: NI, LOT#: NI. UNKNOWN COMPREHENSIVE HUMERAL HEAD, CATALOG#: NI, LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED, AS THE PART NUMBER AND LOT NUMBER ARE UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE: JOSEPH N. LIU, GRANT H. GARCIA, GREGORY MAHONY, HAO-HUA WU, DAVID M. DINES, RUSSELL F. WARREN, LAWRENCE V. GULOTTA (2016) SPORTS AFTER SHOULDER ARTHROPLASTY: A COMPARATIVE ANALYSIS OF HEMIARTHROPLASTY AND REVERSE TOTAL SHOULDER REPLACEMENT. JOURNAL OF SHOULDER AND ELBOW SURGERY BOARD OF TRUSTEES. VOLUME 25, ISSUE 6, PAGES 920¿926. HTTP://DX.DOI.ORG/10.1016/J.JSE.2015.11.003. MEDICAL PRODUCTS: UNKNOWN HEAD, UNKNOWN TAPER, UNKNOWN GLENOID, UNKNOWN GLENOID POST, THERAPY DATE: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 05600, 0001825034 - 2017 - 05601, 0001825034 - 2017 - 05603, 0001825034 - 2017 - 05604. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED 'SPORTS AFTER SHOULDER ARTHROPLASTY: A COMPARATIVE ANALYSIS OF HEMIARTHROPLASTY AND REVERSE TOTAL SHOULDER REPLACEMENT' WHICH IS A RETROSPECTIVE REVIEW OF CONSECUTIVE RSTA AND HHA PATIENTS COLLECTED FROM INSTITUTION'S SHOULDER ARTHROPLASTY REGISTRY. ALL PATIENTS PLAYING SPORTS PREOPERATIVELY WITH MINIMUM ONE YEAR FOLLOW-UP WERE INCLUDED. THIS STUDY IS TO DETERMINE IF PATIENTS WHO ARE NOT CANDIDATES FOR ANATOMIC TSA DUE TO ROTATOR CUFF DYSFUNCTION, RHEUMATOID ARTHRITIS, OR PROXIMAL HUMERAL FRACTURE HAD BETTER RETURN TO SPORTS WHEN THEY UNDERWENT HHA COMPARED WITH RTSA. THE STUDY REPORTED 11 PATIENT DEATHS (4 RTSA GROUP AND 7 HHA GROUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544740 UNKNOWN COMPREHENSIVE HEMI-ARTHROPLASTY STEM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R