Catalog Number 010000589 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 10/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Procode: phx.Udi: (b)(4).Concomitant medical devices: cr vivacit-e 36mm brng std cat# 110031424 lot# 64650795; mini tray std cocr +0 offset cat# 110031399 lot# 64784011; comp rvrs shldr glnsp std 36mm cat# 115310 lot# 885650.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that patient underwent total reverse shoulder arthroplasty.Subsequently, the glenosphere disassociated from the baseplate and patient was revised 3 months later.The glenosphere, humeral tray and bearing were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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