(b)(4) kenjiro yoshida, md , masahiro tada, md, phd , hirokazu yoshida, md , satoshi takei, md, shinichi fukuoka, md, phd , hiroaki nakamura, md, phd "oxford phase 3 unicompartmental knee arthroplasty in (b)(6) ¿ clinical results in greater than one thousand cases over ten years", the journal of arthroplasty 28 suppl.2 (2013) 168¿171 https://www.Sciencedirect.Com/science/article/pii/s088354031300630x?via%3dihub (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 journal article entitled "oxford phase 3 unicompartmental knee arthroplasty in (b)(6) ¿ clinical results in greater than one thousand cases over ten years", by kenjiro yoshida, et al.(2013) abstract there are few reports of the oxford unicompartmental knee arthroplasty (uka) survival rate in asia.This study describes outcomes of 1279 oxford ukas for (b)(6) patients.The mean follow-up was 5.2 years.We divided patients into two groups based on preoperative indications (extended indications group and strict indications group).(b)(4).When we followed inclusion criteria strictly, good clinical results were achieved in asia.This complaint refers to the case 3 reported in table 3, page 170.It was reported that the patient underwent oxford knee revision due to periprosthetic fracture of tibia.Operative findings: osteoporosis.Revised to tka with tibia long stem.
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