Model Number N/A |
Device Problems
Patient Device Interaction Problem (4001); Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 01/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).
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Event Description
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It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture.The patient has indicated a possible revision, but one has not been confirmed yet.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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No devices or photos were received; therefore, the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-rays evaluation report provided by third party hcp states that there is evidence of a vertically oriented medial tibial plateau fracture and associated subsidence of the tibial component.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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