(b)(4).Concomitant medical products: persona cr articular surface, catalog #: 42512000511, lot #: 62903261.Femur cemented cruciate, catalog #: 42502606201, lot #: 62817407.All poly patella, catalog #: 42540000032, lot #: 62859187.Event was initially reported on 0001822565-2018-03216.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.Device remains implanted in patient.
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It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient has reported experiencing pain and that the tibial plate had come apart and is loosening.The patient has been indicated for revision; however, no revision procedure has been reported to date.
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Reported event was unable to be confirmed due to limited information received from the customer.No devices, photos, or medical records were received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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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