Model Number N/A |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 10/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical devices: item number: unknown, item name: unknown glenosphere, lot number: unknown; item number: 110031400, item name: mini humeral tray, lot number: 64691513.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04042, 0001825034 - 2020 - 04044.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported patient underwent a left shoulder revision surgery approximately two months post-implantation due to dislocation.During surgery it was discovered that the poly insert was free floating, and no longer attached to the tray.The tray and liner components were removed and replaced.Attempts have been made and no additional information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.D11: item number: 110030777, item name: versa-dial glenosphere, lot number: 64416224.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further event information available at the time of this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed per the x-rays and visual assessment which stated disassociated humeral poly from humeral tray found.The returned tray and bearing showed damage.The glenosphere was not returned.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision was 2-month status post left total reverse shoulder noted 'did well till suffered an injury and dislocated prosthesis.' disassociated humeral poly from humeral tray found.Replaced tray and poly found stable and good rom.No complications.Device history record was reviewed and no discrepancies relevant to the reported event were found.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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