Two of 5.Reference mfr.Reports: 0001825034-2017-00810, 0001825034-2017-00813, 0001825034-2017-00815, 0001825034-2017-00817.Concomitant medical product: item: 3003940002, refobacin bone cement r 40x2, lot: a350aj2914.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.
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It was reported the patient underwent a left knee arthroplasty.Approximately 4 months post-implantation, the patient experienced an infection which resulted in medical intervention during which the patient's joint was rinsed; and 4 days later, the patient's implants were explanted and replaced.
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