(b)(4).(udi): n/a.Medical product: catalog #: unknown, talar, lot # unknown; catalog #: unknown, articular surface, lot # unknown.Chen j, akoh cc, somerson js, easley me, adams sb, deorio jk, nunley ja.Analysis of 408 total ankle arthroplasty adverse events reported to the us food and drug administration from 2015 to 2018.Foot ankle specialist (2020), doi:10.1177/1938640020919538.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02738 and 0001822565-2020-02787.Location unknown.
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It was reported that the study reported four miscellaneous failures.It was indicated that the miscellaneous failure could have been pain without known cause, stiffness, metal allergy or painful hardware; however, it was not indicated which specific complication occurred with the zb product.
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