(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02806.0001822565-2020-02807.Study was conducted between (b)(6) 2013 and (b)(6) 2016.Concomitant medical products: item# unknown talar component; lot# unknown.Item# unknown tibial base component; lot# unknown.(b)(6).Foreign report source: (b)(6).Literature - retrieved from: maccario c, tan ew, silvestri cad, indino c, kang hp, usuelli fg.Learning curve assessment for total ankle replacement using the transfibular approach.Foot and ankle surgery.2020.Doi:10.1016/j.Fas.2020.03.005.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.
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It was reported approximately one (1) week ago, a journal article was retrieved from foot and ankle surgery (2020) that reported a study from italy that looked at the learning curve assessment for total ankle replacement using the transfibular approach.The study reported a patient whom experienced delayed would healing and required hardware removal, negative pressure wound therapy and ultimately free flap reconstruction three (3) months after the index surgery.
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No product was returned; visual and dimensional evaluations could not be performed.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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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