Device Problems
Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
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Patient Problems
Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event report was received through clinical data collection activities.Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2012.Revision of shoulder components due to rotator cuff tear and glenoid loosening.The case report form indicates this event is definitely not related to devices or procedure.
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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 1038671-2018-00450, 1038671-2018-00451, 1038671-2018-00452 and 1038671-2018-00454.
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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 rotator cuff tear and glenoid loosening is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.
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Search Alerts/Recalls
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