Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.
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Event Description
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It was reported that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, the patient suffered a non-displaced tibial plateau fracture one month post-operatively which was treated conservatively and healed.The x-ray showed that the bone was crushed.No corner pin was used.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).Udi : (b)(4).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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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).Reported event is considered confirmed as review of the x-ray review from mmi states that there was a periprosthetic fracture of the medial tibial plateau.Also, there are radiolucent lines at the tibial tray component metal-bone interface laterally (zone 5) and anteriorly, consistent with loosening of the tibial tray component.Device history record was reviewed and no discrepancies relevant to the reported event were found.An x-ray review showed that the bone quality is shown as osteopenic.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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