In a review of the labeling it is a known complication that a patient's age, weight, or activity level 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 instability of the shoulder joint device is related to patient underlying conditions to include obesity, cardiac diseases that inhibit healing and chronic left shoulder maladies.This device is used for treatment, not diagnosis.
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Information reported is via ufr# (b)(4).No additional information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00475, 1038671-2018-00476, 1038671-2018-00477, 1038671-2019-05004.
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