Model Number N/A |
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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Manufacturer Narrative
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(b)(4).Sm hybrid glenoid base 4mm cat# 113952 lot# 576650.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 - 01329.
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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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This follow-up report is being submitted to relay additional information.Part pt-113950: visual examination of the provided pictures identified the post is fractured.As the products have not returned further dimensional and visual analysis could not be performed.Part pt-113950: lot identification is necessary for review of device history records, lot identification was not provided.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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