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Device Problems
Output Problem (3005); Positioning Problem (3009)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/22/2022 |
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 on (b)(6) 2022 by a sales representative via phone that an unknown arthrex reverse shoulder baseplate was removed because the glenoid was unable to hold baseplate.Rep stated patient had radiation treatment on the shoulder which compromised the bone quality.After use, device removed fell out of the original seating position.
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Search Alerts/Recalls
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