Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Information (3190)
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Event Date 04/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: unk oxford tibial component, catalog #: unk, lot #: unk; medical product: unk oxford bearing , catalog #: unk, lot #: unk.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00455, 3002806535-2019- 00456.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not return.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, a revision procedure was performed due to loosening.
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Event Description
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, a revision procedure was performed due to loosening.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz d rm pma, catalog #: 154725, lot #: 946910, medical product:oxf anat brg rt lg size 3 pma , catalog #: 159582, lot #: 677400.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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