(b)(4).Report source: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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 remains implanted.
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(b)(4).Reported event was confirmed by review of x-rays provided.Early postop x-ray shows a fracture at the medial cortex of the medial tibial plateau in vicinity of a previously visualized osteophyte.X-rays obtained 2 weeks postoperatively show a vertical component of fracture of the medial tibial plateau, at the medial margin of the tibial component.Device history record was reviewed and no discrepancies were found.No compatibility issues were noted.Root cause was unable to be determined.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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