Model Number N/A |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problem
Joint Laxity (4526)
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Event Date 09/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).Concomitant medical product - left standard titanium mandibular component: catalog #: 24-6551ti; lot #: 613190a.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that a revision was performed due to non-integration of hardware screws causing mobility of the left prosthesis.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.Part and lot identification are necessary for review of device history records, neither were provided for the screws.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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