(b)(4).Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system." pg.1-33.Reference journal article attached.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A review of the complaint history determined that no further action is required.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Concomitant devices - explor 16 x 20 mm implant modular radial head catalog #: 11-210025 lot #: ni.Initial reporter - the article was written by schuyler j halverson, mihir j desai and donald h lee.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-02204 ).
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