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Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Joint Disorder (2373); No Code Available (3191)
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Event Date 04/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2017.Revision of right shoulder components due to a postero-sup rotator cuff tear and the glenoid becoming dislodged from the pegs.
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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.The cause of the postero-superior rotator cuff tear, with the polyethylene glenoid dislodged from the pegs is most likely related to the patient's underlying conditions.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 three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00266, 1038671-2018-00691.
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Search Alerts/Recalls
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