Patient received a right revision of the unicompartmental knee due to pain secondary to loosening.Upon entering the joint, the femoral component was grossly loose at an unknown interface and easily removed.There was no reported product problem of the explanted tibial tray or insert.There was no indication of infection or inflammation in the knee.The patient was revised with competitor products.The patient had the postoperative complications of acute kidney injury, hypotension, and acute anemia secondary to anesthetic medication imbalance and dehydration.The patient was treated with supplemental oxygen, medication adjustment, and aggressive oral and iv fluid intake.The patient did not require a prolonged hospital stay.On (b)(6) 2018, the patient reported healing nicely with no further complications.The revision procedure is captured on (b)(4).Doi: (b)(6) 2012 (bilateral), dor: (b)(6) 2018 (right), doe: 20 nov 2018 (right postoperative aki and anemia), dor: (b)(6) 2019 (left).
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
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