Model Number N/A |
Device Problems
Material Erosion (1214); Particulates (1451)
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Patient Problem
Swelling (2091)
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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: biomet microfixation unknown fossa screws, catalog #: ni lot #: ni.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: 0001032347-2019-00201, 0001032347-2019-00204 & 0001032347-2019-00205.
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Event Description
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It was reported that a revision is planned for the patient due to an allergic reaction and the presence of polyethylene particles.The patient has developed periodic facial swelling throughout the last year.A biopsy of the site showed polyethylene particles; no infection was found.The patient will have a revision due to wear of the fossa.Allergy testing came back as reactive; an all titanium implant is needed.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The parts were not returned for evaluation; therefore, no functional testing or inspections could be performed.However, the complaint is considered confirmed as tmjpm-2570 was requested for manufacture, and the most likely underlying cause of the complaint is patient condition.There are no indications of manufacturing defects.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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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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