Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/12/2024 |
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 small left fossa component catalog #: 24-6563 lot #: 014110; zimmer biomet tmj system left standard mandibular component catalog #: 24-6551 lot #: 980400.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.
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Event Description
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It was reported that the patient underwent a revision procedure approximately 18 years post implantation due to unknown reasons.Attempts have been made and no additional information is available at the time of this report.
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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.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 related to the reported event.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that 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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Search Alerts/Recalls
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