Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problem
Pain (1994)
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Event Date 09/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2017 - 09723.3002806535 - 2017 - 00984.(b)(4).Concomitant products: 161473 oxf twin peg cmntls lot r2409853a.159540 oxf anat brg lt sm lot 603270.Us166845 oxford cementless tibia a lm lot r3050449a.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the patient twisted the knee and felt a "pop".Pain and tenderness were associated with the event.The patient was not revised and the event was treated with medicine and a brace.No further information has been made available at this time.
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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 the customer.Device history record (dhr) was reviewed and no discrepancies were found.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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