(b)(4).J.Blaney, h.Harty, e.Doran, s.O¿brien, j.Hill, i.Dobie, d.Beverland (2017) five-year clinical and radiological outcomes in 257 consecutive cementless oxford medial unicompartmental knee arthroplasties.Bone joint j 2017;99-b:623¿31.Http:/bjj.Boneandjoint.Org.Uk/content/99-b/5/623.Report source, foreign - event occurred in (b)(6).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 "five-year clinical and radiological outcomes in 257 consecutive cementless oxford medial unicompartmental knee arthroplasties." by blaney, j.Et al.(2017).This complaint refers to the reported right knee re-operation due to periprosthetic fracture (vertical displaced tibial fracture of the medial tibial condyle): two weeks post operatively.Cause unknown but likely to be connected to surgery.Open reduction and internal fixation performed about 2 weeks after index surgery.
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