Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 09/21/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Uk.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
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Event Description
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It was reported through a study that a patient underwent an arthroplasty approximately 7 years ago.Subsequently, patient underwent re-operation approximately 6 months later due to nonunion.The nail was removed and a plate was implanted.No obvious reason for the nonunion.Attempts have been made and there is no further information at this time.
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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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(b)(4).H6: proposed annex g code: mechanical (g04) - im nail.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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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