Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product - unknown oxford tibial component.Therapy date - (b)(6) 2018.Medical product - unknown (b)(6) bearing.Therapy date - (b)(6) 2018.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-0883 and 3002806535-2018-0885.
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Event Description
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It was reported that a patient underwent an initial left knee procedure, subsequently the patient was revised due to a fractured hip.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.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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Search Alerts/Recalls
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