In a review of the labeling it is a known complication that a patient's age, weight, activity level and/or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the revision for the shoulder joint device is related to trauma from the patient fall.This device is used for treatment, not diagnosis.
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It was reported that the patient fell and most likely caused the anatomic glenoid cage to break in several pieces and the poly to come loose.The patient was converted to a reverse shoulder and everything was reported to look good.There is no indication that the devices malfunctioned.No additional information is provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00797, 1038671-2017-00801, and 1038671-2017-00803.
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