Kort, n.P., jos j.A.M.Van raay, & horn, j.J.(2006).The oxford phase iii unicompartmental knee replacement in patients less than 60 years of age.Knee surgery, sports traumatology, arthroscopy, 15(4), 356-360.Doi:10.1007/s00167-006-0204-9.The product was not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Without the opportunity to examine the complaint product, root cause cannot be determined.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.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.This report is being submitted late as it has been identified in remediation.
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One (b)(6) patient was identified in the article that underwent decompression of all four compartments of the lower leg, 2 weeks post uka the patient underwent an arterial bypass with autogenous vein.It was further reported that the surgery had good results; however, there is still slight neurological (n.Peroneus) impairment there has been no further information provided.
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