Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Edema (1820); Fever (1858); Pain (1994)
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Event Date 06/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf anat brg lt lg size 3 pma catalog #: 159554 lot #: 754110, medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 2446499.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00861, 3002806535-2019-00859.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent an initial left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from (b)(6).The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.
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Event Description
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It was reported that a patient underwent an initial left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from italy.The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.
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Manufacturer Narrative
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(b)(4).D11: medical product: oxf anat brg lt lg size 3 pma, catalog #:159554, lot #: 754110.Medical product:oxf uni tib tray sz e lm pma, catalog #: 154726, lot #: 2446499.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00861-1, 3002806535-2019- 00859-1.This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g4, g7, h1, h2, h6, h10.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.The clinical report form indicated that the event is irrelevant to the device.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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