Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz d lm pma catalog #: 154724 lot #: 941490, medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 790370.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.Subsequently, a bearing revision was performed due to unknown reason.This patient had an infection and the surgeon did an i&d and changed the poly.
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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 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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Event Description
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It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, a bearing revision was performed due to unknown reason.This patient had an infection and the surgeon did an i&d and changed the poly.
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Search Alerts/Recalls
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