Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign source: (b)(6).Concomitant medical products: medical product: oxf anat brg lt md size 7 pma, catalog #: 159551, lot #: 1397906, medical product: unknown oxford femoral component, catalog #: not reported, lot #: not reported.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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Event Description
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The hospital reported that a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure was performed due to septic tibial loosening and secondary tibial fracture.
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Manufacturer Narrative
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(b)(4).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.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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The hospital reported that a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure was performed due to septic tibial loosening and secondary tibial fracture.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.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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The hospital reported that a patient underwent an initial knee arthroplasty on an unknown date.Subsequently, a revision procedure was performed due to septic tibial loosening.New information received confirms that no tibial fracture occurred.
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Search Alerts/Recalls
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