Catalog Number 300-10-15 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Joint Disorder (2373)
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Event Date 05/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Previous surgery: (b)(6) 2016.Revision of left shoulder components due to subscapularis tear.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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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.Postoperative rotator cuff tear is a known complication associated with total shoulder arthroplasty.Rotator cuff strains or tears are caused by overuse or acute injury.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 cause of the subscapularis rotator cuff tear is most likely related to the patient's underlying conditions of age, degenerative joint disease and previous shoulder maladies.This device is used for treatment, not diagnosis.
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Event Description
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No addition information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00323, 1038671-2018-00325, 1038671-2018-00326 and 1038671-2018-00327.
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Search Alerts/Recalls
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