Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Erosion (1750)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: vngd ps tib brg 63/67x12 catalog # ep-183622 lot # 825360; van ps open intl fem-rt 62.5 catalog # 183106 lot # 476870; palacos cement catalog # unknown lot # 1474427.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported a patient is experiencing tibial loosening and a peg rubbing the bone, creating a groove six years post implantation.Attempts to obtain additional information have been made; however, no more is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates no intra-op complications.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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