This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device in the united states under 510k number k023357.This report is number 1 of 2 mdrs filed for the same patient (reference 3002806535-2016-00187 / 00188).Remains implanted.
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