Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Initial reporter - the article was written by omar k.Alnachoukati, keith berend, mike kolczun, roger emerson, adolf lombardi, david mauerhan, and john barrington.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "major surgical risks associated with anesthetic including, brain damage, pneumonia, blood clots, heart attack, and death." number 12 states, "inadequate range of motion due to improper selection or positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." number 20 states, "persistent pain." product location unknown.
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Information was received based on review of a journal article titled, "multi-center study of 825 phase iii oxford medial compartmental arthroplasty knees: an average ten-year survival analysis in the united states." which aimed to examine the first long-term survivorship with a large patient sample size study in the united states looking at various aspects of the phase iii oxford design while also addressing recent advancements that can help aid the uka process and improve partial knee survivorship.A patient was identified that underwent a left partial knee arthroplasty.Patient follow-up results provided at three months post-implantation indicates evidence of pain, difficulty using stairs and it was reported the patient expired on an unknown date due to unknown reasons.
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