(b)(4).Date of event: published online jan 31, 2018.Concomitant medical products: unknown, unknown tibial component, unknown report source, foreign - the event occurred in (b)(6).Report source, literature: aubret, s., merlini, l., fessy, m., besse, j.L.(2017).Poor outcomes of fusion with trabecular metal implants after failed total ankle replacement: early results in 11 patients.Orthopaedics & traumatology: surgery & research, 104(2), 231-237.Doi: 10.1016/j.Otsr.2017.11.022.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01859.[(b)(4)].Product location unknown.
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