Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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This complaint is from a literature source.The following literature cite has been reviewed: wang q, tan g, mohammed a, zhang y, li d, chen l, kang p.Adding corticosteroids to periarticular infiltration analgesia improves the short-term analgesic effects after total knee arthroplasty: a prospective, double-blind, randomized controlled trial.Knee surg sports traumatol arthrosc.2021 mar;29(3):867-875.Doi: 10.1007/s00167-020-06039-9.Epub 2020 may 2.Pmid: (b)(4).Objective and methods: patients receiving depuy sigma fixed-bearing or rotating-platform, posterior stabilized total knee prostheses, were randomized to the corticosteroid or control group (double-blinded).The patients in the corticosteroid group received a periarticular infiltration of an analgesic cocktail of ropivacaine, epinephrine, and dexamethasone.Dexamethasone was omitted from the cocktail in the control group.The primary outcomes were postoperative pain [assessed using a visual analog scale (vas)], time until the administration of first rescue analgesia of morphine sulfate, overall morphine consumption, and postoperative inflammatory biomarkers [c-reactive protein (crp) and interleukin-6 (il-6)].The secondary outcomes were functional recovery, assessed by the range of knee motion, quadriceps strength, and daily ambulation distance.The tertiary outcomes included postoperative adverse effects.Results: adding corticosteroids to an analgesic cocktail for pia can mildly improve early pain relief and accelerate recovery in the first 24 h after total knee arthroplasty.Tertiary adverse events (complications): 32: post-op nausea; 18: post-op vomiting; 28: post-op wound swelling; 4: delayed wound healing; 3: deep venous thrombosis; 9 : chronic pain; 2: nerve damage (foot-drop - resolved within 24 hours).
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