BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER SYSTEM

    MDR report key: 6883291 · Received September 20, 2017

    Report

    Report Number
    MW5072258
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    January 28, 2014
    Report Date
    August 7, 2017
    Manufacturer
    BIOMET
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DISLOCATION OF THE RIGHT REVERSE TOTAL SHOULDER IMPLANT IN (B)(6) 2014 AND THEN AGAIN IN (B)(6) 2014. RIGHT CHRONIC IRREPARABLE ROTATOR CUFF TEAR AND PSEUDOPARALYSIS OF THE RIGHT UPPER EXTREMITY NOTED ON (B)(6) 2014. THE IMPLANT BECAME DISLOCATED AFTER THE SURGERY ON (B)(6) 2014 NECESSITATING A REVISION SURGERY IN (B)(6) 2014. IMPLANT BECAME DISLOCATED AFTER THE REVISION SURGERY ON (B)(6) 2014, SO A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. RIGHT UNSTABLE REVERSE TOTAL SHOULDER REPLACEMENT WITH RECURRENT DISLOCATION NOTED ON (B)(6) 2014. TIMELINE: CHRONIC IRREPARABLE ROTATOR CUFF TEAR AND PSEUDOPARALYSIS OF THE RIGHT UPPER EXTREMITY NECESSITATING SURGERY. ON (B)(6) 2014: RIGHT REVERSE TOTAL SHOULDER SURGERY. ON (B)(6) 2014: DISLOCATED RIGHT REVERSE SHOULDER PROSTHESIS NECESSITATING A REVISION SURGERY ON (B)(6) 2014. ON (B)(6) 2014: ANOTHER DISLOCATION OF THE RIGHT REVERSE TOTAL SHOULDER PROSTHESIS NECESSITATING ANOTHER REVISION SURGERY ON (B)(6) 2014. PARTS USED DURING SURGERIES: BIOMED COMPREHENSIVE REVERSE SHOULDER 6.5 MM CENTRAL SCREW: REF (B)(4), LOT 203870, EXP 11/2023; BIOMED FIXED LOCKING SCREW: REF (B)(4), LOT 465180, EXP 05/2023; BIOMED VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR: REF (B)(4), LOT 689660, EXP 12/2023; BIOMET COMPREHENSIVE SHOULDER SYSTEM PRIMARY LENGTH SHOULDER STEM: REF (B)(4), LOT 781530, EXP 03/2021; BIOMET FIXED LOCKING SCREW: REF (B)(4), LOT 172390, EXP 04/2023; BIOMET FIXED LOCKING SCREW: REF (B)(4), LOT 027490, EXP 07/2023; BIOMET COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING/STANDARD: REF (B)(4), LOT 22080, EXP 11/2018. ON (B)(6) 2014: BIOMED COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD: REF (B)(4), LOT 278670, EXP 12/2018; BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY: REF (B)(4), LOT 116690, EXP 02/2024. GLENOSPHERE 41 +6, HUMERAL TRAY 44+5, STANDARD E1 POLY BEARING. BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY: REF (B)(4), LOT 477950, EXP 12/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658086 COMPREHENSIVE REVERSE SHOULDER SYSTEM COMPREHENSIVE REVERSE SHOULDER SYSTEM KWS BIOMET REF115330 827490
    658087 COMPREHENSIVE REVERSE SHOULDER SYSTEM COMPREHENSIVE REVERSE SHOULDER SYSTEM KWS BIOMET REF 115310 283600
    658088 BIOMET FIXED LOCKING SCREW BIOMET FIXED LOCKING SCREW HRS BIOMET REF 180502 828450

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S