(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 arthroplaties: 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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Information received based on review of a journal article, entitled "eight hundred twenty-five medial mobile-bearing unicompartmental knee arthroplaties: the first 10-year us multi-center survival analysis" by omar k.Alnachoukati et al.(2017).This complaint refers to the reported 7 oxford knee revision surgeries due to femoral loosening.There were reported 1 revision in clinic 1, 5 revisions in clinic 2 and 1 revision in clinic 3.(table 1, page 4).
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Upon receipt of additional information, it has been determined that these events have previously been reported via the following submissions: 3002806535-2016-00390, 3002806535-2016-00410, 3002806535-2016-00416, 3002806535-2016-00425, 3002806535-2016-00497, 3002806535-2016-00619, 3002806535-2016-00629.
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