Device Problem
Malposition of Device (2616)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent placement of an external fixation device.Subsequently, forty days later, underwent a readjustment due to loss of position.The readjustment was unsuccessful and will plan for an orif.No additional information is available.
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Manufacturer Narrative
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(b)(4).Foreign source: united kingdom.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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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