BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5072527

    MDR report key: 6903579 · Received September 29, 2017

    Report

    Report Number
    MW5072527
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    September 14, 2015
    Report Date
    August 8, 2017
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A PROXIMAL HUMERUS FRACTURE OF THE RIGHT SHOULDER TREATED WITH AN INTRAMEDULLARY PLATE AND ROD. I HAD A FAILURE OF THE FIXATION AND GRADUALLY SHOWED DETERIORATION OF FUNCTION OF THE RIGHT SHOULDER. I REACHED A POINT WHERE I HAD ESSENTIALLY A CUFF TENDON ARTHROPATHY OF THE RIGHT SHOULDER AND UNDERWENT A RIGHT REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2015. I HAD A DISLOCATION AND HAD A REVISION SURGERY IN (B)(6) 2015. I HAD MULTIPLE DISLOCATIONS POSTOPERATIVELY AND HAD THE IMPLANT REMOVED IN (B)(6) 2015. ON (B)(6) 2015: BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY: REF 115375, LOT 81880, EXP 07/22/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING: REF XL-115354, LOT 634580, EXP 07/22/2020; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW: REF 180553, LOT 820860, EXP 07/22/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW: REF 115397, LOT 430520, EXP 06/18/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE: REF 115310, LOT 115310, LOT 999180, EXP 08/07/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER LOCKING SCREW: REF 180552, LOT 039010, EXP 08/08/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER PRIMARY STANDARD LENGTH SHOULDER STEM: REF 113649, LOT 153780, EXP 11/2023; BIOMET COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE: REF 010000688, LOT 793560, EXP 08/28/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING: REF CL-115363, LOT 599600, EXP 07/22/2020; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW: REF 180550, LOT 820680, EXP 07/20/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/LOCKING RING: REF 115370, LOT 961720, EXP 08/07/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW: REF 180660, LOT 860920, EXP 07/22/2025.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R| S