Catalog Number 856210012 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 08/28/2017 |
Event Type
Injury
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Event Description
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It was reported that the patient had redness, swelling and suspicion of infection over the distal fibula after the procedure.The event was resolved after 2 weeks of antibiotics administration.
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Manufacturer Narrative
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(b)(4).Report source: foreign: (b)(6).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 report will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 available at the time of this report.
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Search Alerts/Recalls
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