Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Arthritis (1723); No Information (3190)
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Event Date 03/27/2017 |
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) 2017.Medical product - unknown oxford bearing, therapy date - (b)(6) 2017.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: 3002806535-2018-00146 and 3002806535-2018-00148.
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Event Description
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It was reported the patient underwent a partial oxford knee procedure and subsequently the patient underwent a revision due to unknown reasons.The patient was implanted with total knee implants during the revision procedure.
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Manufacturer Narrative
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(b)(4).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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The event is not reportable because it was due to disease progression.
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Event Description
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The revision was due to the patient's arthritis spreading to the lateral compartment.
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Search Alerts/Recalls
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