(b)(4).Omar k.Alnachoukati, ms , john w.Barrington, md , keith r.Berend, md ,michael c.Kolczun, md , roger h.Emerson, md , adolph v.Lombardi jr., md,david r.Mauerhan, md.(2017) eight hundred twenty-five medial mobile-bearing unicompartmental knee arthroplasties: the first 10-year us multi-center survival analysis.The journal of arthroplasty, 2017,https://doi.Org/10.1016/j.Arth.2017.10.015.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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Upon receipt of additional information, it has been determined that these events have previously be submitted via the following submissions: 3002806535-2016-00428, 3002806535-2016-00429, 3002806535-2016-00467, 3002806535-2016-00489, and 3002806535-2016-00508.
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