BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ACROM XL 44-41 STD +3; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Date 03/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 7 states, "inadequate range of motion due to improper selection or positioning of components, lack of rotator cuff, and inadequate function of the deltoid." number 12 states, "wear and/or deformation of articulating surfaces." number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2016-03952/ 03978 / 03979 and 1825034-2013-01519).
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Event Description
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Patient alleges that he underwent a left shoulder revision due to pain, decreased range of motion, and incorrect selection of implant size approximately three years post-implantation.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Operative reports noted that the patient had adhesions and scar tissue present between the deltoid and proximal humerus, soft tissue noted around the humeral stem, impingement, and erosions on the bearing.The humeral bearing, tray, glenosphere, and taper adaptor were removed and replaced.
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