Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/02/2023 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Concomitant medical product - zimmer biomet tmj system small left fossa component catalog #: 24-6563 lot #: 980840a.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2023-00091.
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Event Description
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It was reported that the patient underwent a left tmj procedure approximately 3 years ago.Subsequently, a revision was performed approximately 2 years post implantation due to bone loss resulting in a screw loosening.Attempts have been made and no further information has been provided.
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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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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.Radiographs were provided and reviewed by a health care professional.A single post revision image was reviewed.No other medical records were supplied.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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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Search Alerts/Recalls
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