ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, 5MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Model Number UNIVERS REVERS HUMERAL STEM, 5MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 02/28/2023 |
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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On 3/1/2023, it was reported by a sales representative via email that a shoulder arthroplasty revision surgery took place on (b)(6) 2023 due to an infection.The surgeon removed an ar-9560-28 arthrex univers revers modular glenoid system modular baseplate, an ar-9502f-42lcpc arthrex univers revers suture cup, an ar-9564-2842 arthrex univers revers modular glenoid system glenosphere, an ar-9503l-03 arthrex univers revers humeral insert, (2) ar-9563-20 univers revers modular glenoid system peripheral locking screw, an ar-9562-28nl univers revers modular glenoid system peripheral non-locking screw, an ar-9562-40nl univers revers modular glenoid system peripheral non-locking screw, an ar-9561-25p univers revers modular glenoid system central post modula, and an ar-9501-05p univers revers humeral stem.
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Search Alerts/Recalls
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