Patient received a right primary attune to treat pain secondary to advanced osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, the surgeon identified and excised a small cyst.The tibial tray was loosened and debonded at the cement to implant interface and removed.The femoral component was well-fixed but revised.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The patient was revised with a depuy construct utilizing depuy cement.The procedure was completed without complications.Doi: (b)(6) 2015, dor: (b)(6) 2020, right knee.
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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