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.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.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 surgical revision to the right shoulder joint devices is most likely due to the patient's underlying conditions, including age and other shoulder maladies.This device is used for treatment, not diagnosis.No information has been provided.Information not provided (as needed).
|