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Catalog Number 310-01-47 |
Device Problems
Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Failure of Implant (1924)
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Event Date 08/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the device was not returned.Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2012.Revision due to patient fall, causing the poly to become loose on the glenoid side.
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Event Description
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Due to an insufficient rotator cuff, the surgeon had decided to remove all the primary components, except for the humeral stem and perform a reverse shoulder.No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00627, 1038671-2017-00628, and 1038671-2017-00630.
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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, activity level, 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 shoulder joint device is related the patient fall.This device is used for treatment, not diagnosis.
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Search Alerts/Recalls
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