(b)(4) this complaint refers to the study entitled "ten-year survival of minimally invasive cementless oxford phase 3 unicompartmental knee replacement" by campi s, et al.(2017), presented at european knee society meeting 2017.This journal article could not be located however, the summary of the reported adverse events has been found in the supplemental material within mr mohammad's article which has been attached.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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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A journal article entitled "long-term outcomes of over 8,000 medial oxford phase 3 unicompartmental knees¿a systematic review", by mohammad hr, (2017), investigated under (b)(4), was based on a review of 15 other publications.Separate complaints have been raised to investigate journals mentioned in this medical paper.This complaint refers to the study entitled "ten-year survival of minimally invasive cementless oxford phase 3 unicompartmental knee replacement" by campi s, et al.(2017), presented at european knee society meeting 2017.This journal article could not be located however, the summary of the reported adverse events has been found in the supplemental material within mr mohammad's article.There were reported 1 knee revisions due to acl tear.
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