(b)(4).Concomitant medical products - explor radial head: catalog # 11-210033, lot # ni.(b)(6).Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system" journal title.37:853-858.The reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the lot number is unknown.A 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-02379.
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