Model Number UNIVERSAL GLENOID - CENTRAL SCREW 20MM |
Device Problem
Degraded (1153)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that one year after the implantation of a right shoulder total endo-prosthesis eclipse on (b)(6) 2016, polyethylene degradation was identified post-operatively.This resulted in a bone defect which led to a revision surgery to change the implant to an inverse prosthesis.
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Search Alerts/Recalls
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