BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5072599

    MDR report key: 6914004 · Received October 4, 2017

    Report

    Report Number
    MW5072599
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    October 24, 2016
    Report Date
    August 7, 2017
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FAILED NON-OPERATIVE TREATMENT OF RIGHT SHOULDER ROTATOR CUFF ARTHROPATHY NECESSITATED A RIGHT SHOULDER REVERSED TOTAL SHOULDER ARTHROPLASTY IN (B)(6) 2016. A REVISION WAS PERFORMED IN (B)(6) 2017 DUE TO INSTABILITY. A CLOSED REDUCTION WAS PERFORMED PRIOR TO THIS SURGERY, BUT IT WAS UNSUCCESSFUL. AN X-RAY WAS TAKEN ON (B)(6) 2017 SHOWED THAT THE HUMERAL COMPONENT WAS DISLOCATED ANTERIORLY IN RELATION TO THE GLENOID COMPONENT. THERE WAS A PERIPROSTHETIC FRACTURE IN THE REGION OF THE GLENOID COMPONENT WHICH WAS DISPLACED POSTERIORLY. THE FRACTURE LINE EXTENDED INFERIORLY THROUGH THE BODY OF THE SCAPULA. THE INFERIOR EXTENT OF THIS FRACTURE WAS NOT IMAGES. THERE WAS NO EVIDENCE OF A PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE HUMERAL COMPONENT. DURING THE (B)(6) 2016 SURGERY, THE HUMERAL HEAD CUTTING GUIDE WAS PLACED IN BUT ULTIMATELY NOT USED BECAUSE THE SAW HAD FALLEN. BIOMET COMPREHENSIVE REVERSE SHOULDER: REF 010000589, LOT 258340, EXP 08/22/2028: BIOMET COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW: REF 115397, LOT 304380, EXP 12/03/2025; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW: REF 180553, LOT 408770, EXP 06/08/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED REVERSE SHOULDER FIXED LOCKING SCREW: REF 180550, LOT 541520, EXP 06/17/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW; REF 180552, LOT 135430, EXP 05/12/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER STEINMANN PIN: REF 405800, LOT 354250, EXP 08/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER PERIPHERAL SCREW DRILL BIT: REF 405889, LOT 608460, EXP 09/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER PERIPHERAL SCREW BIT: REF 405889, LOT 608460, EXP 09/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER STEINMANN PIN: REF 405880, LOT 354260, EXP 08/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER FIXED LOCKING SCREW: REF 180556, LOT 566640, EXP 12/2023 (PUT IN AND TAKEN OUT); BIOMET COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE W/HUMERAL BEARING: REF 115310, LOT 167260, EXP 11/02/2020; BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING: REF 115370, LOT 512940, EXP 09/16/2026; BIOMET COMPREHENSIVE REVERSE SHOULDER MINI HUMERAL STEM: REF 113636, LOT 021260, EXP 10/11/2025;, BIOMET COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING: REF XL-115363, LOT 812150, EXP 07/18/2021.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S