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 loosening of 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 from the united kingdom that a patient experienced a revision surgery after a fall.The patient presented to the healthcare provider with poor mobility (stiffness) and had an x-ray that showed device loosening.The patient reported that he had fallen.Revision of the shoulder components is due to loosening of the baseplate, all implants were removed, and a spacer as put in situ."revision surgery to follow".No additional information has been provided, follow up attempts for information have been made.There is no indication that the devices malfunctioned.No additional information is provided.This is one of eleven products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00810, 1038671-2017-00811, 1038671-2017-00812, 1038671-2017-00813, 1038671-2017-00814, 1038671-2017-00815, 1038671-2017-00816, 1038671-2017-00817, 1038671-2017-00818 and 1038671-2017-00819.
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