Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet tmj system left narrow mandibular component catalog #: 01-6551 lot #: 797740d.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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: 0001032347-2023-00217.
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Event Description
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It was reported that the patient underwent a left tmj replacement approximately four years ago.Subsequently, the patient is experiencing pain near the left ear and numbness on the left side of the face.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.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 is available at the time of this report.
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Search Alerts/Recalls
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