Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Perforation (2001); Skin Tears (2516)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Concomitant medical products: item# pp-0357, lot# 731440, carney prebent t1 rcn plate aoc.Initial reporter: patient's spouse.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: 0001032347-2022-00343.
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Event Description
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It was reported, that the patient has a left tmj implant that is coming through his skin.A revision procedure is being planned.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 report 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D6: explant date; unknown date in january 2023.This report is being submitted to update additional information in sections b3, b4, b5, b7, d6, e1, e2, e3, g3, g6, h2, h3, h6, and h10.
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Event Description
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It has been further reported that the patient underwent a revision due to the implant protruding through the skin as well as being infected.The reporter stated that the patient had passed away, but that the passing was not jaw-related.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The reported event is confirmed, based on provided photos.
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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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