Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet right standard mandibular component catalog #: 24-6545 lot #: 642850b; zimmer biomet tmj small right fossa component catalog #: 24-6562 lot #:691270b.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00004.
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Event Description
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It was reported that the patient underwent tmj replacement surgery approximately eight years ago.Subsequently, the patient was revised approximately two months ago due to unknown reasons.Attempts have been made and no further information has been provided.
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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.Medical records were not provided.Review of the device history records 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 available at the time of this report.
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Search Alerts/Recalls
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