This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: radiology from (b)(6) 2017 shows complete displacement of osteotomy.Medical records from (b)(6) 2018 note pain, stiffness, hallux valgus not corrected, shortening of metatarsal.On (b)(6) 2018 revision of right foot due to a malunion of hallux valgus surgery.Right mtp1 arthrodesis with harvested bone graft placed.No complications.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.
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