(b)(4).Udi # n/a.Barbara h currier, paul j hecht, james a.Nunley ii, michael b mayor, john h currier, douglas w.Van citters (2018).Ankle arthroplasty: what retrievals can tell us.American orthopaedic foot & ankle society.Https://doi.Org/10.1177/1071100718802589.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 - 06301, 0001822565 - 2018 - 06300.Not returned to manufacturer.
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It has been reported in the research article that, one patient had an ankle arthroplasty.Subsequently patient was revised approximately 0.8 years post initial surgery due to malposition.Pain, deformity and failure of the fibular fixation/syndesmotic repair, with subsidence of the tibial component were further reported.Burnishing was also noted on the retrieved poly.Attempts have been made and no further information has been provided.
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