Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The customer has indicated the product will be returned to zimmer biomet for investigation.Once additional information is obtained a follow-up mdr will be submitted.Device location unknown.
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Event Description
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It was reported that during an initial knee procedure that the articular surface provisional broke into two pieces upon insertion by surgeon.All pieces were removed from patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that during knee procedure that the articular surface provisional broke into two pieces upon insertion by surgeon.All pieces were removed from patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided there are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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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