Catalog Number 113952 |
Device Problems
Material Erosion (1214); Detachment of Device or Device Component (2907)
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Patient Problems
Failure of Implant (1924); Metal Related Pathology (4530)
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Event Date 05/19/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a revision procedure due to a disassociated post and glenoid which caused metallosis and wear.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: pt hybrid glen post regenerex, cat# pt-113950, lot#ni.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01330.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Part 113952: visual examination of the provided pictures identified the glenoid has a hole worn through it, and the articulating surface is worn in the form of nicks and scratches.One of the posts on the back of the poly is deformed and some bone cement can be visualized; however, it is unknown if this deformation happened in-vivo or during explanting.As the products have not returned further dimensional and visual analysis could not be performed.Part 113952: review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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