Literature article entitled ¿presurgical optimization and opioid-minimizing enhanced recovery pathway for ambulatory knee and hip arthroplasty: postsurgical opioid use and clinical outcomes" written by alaine van horne and james van horne, md.Published by arthroplasty today published online/accepted by publisher 20 august 2019 was reviewed.The article's purpose was to performs a retrospective review of ¿outcomes from an eras pathway designed to maximize patients¿ eligibility for ambulatory tka/tha while reducing costs, complications, and postsurgical opioid use.¿ data was compiled relating to 220 unique, consecutive patients who underwent 251 total knee arthroplasty or total hip arthroplasty surgeries (tka 113, tha 138).No patient was excluded from the analyses.Patients¿ mean age was 58 (22-84) years, 49% were women, 51% were men.27 patients had medical history of heart disease, and 15 patients had a medical history of diabetes.Specific patient identifiers were not provided.Cement manufacturer was not identified.Depuy products: sigma total knee construct and corail stem and pinnacle cup construct.Total knee adverse events (all occurring within 60 days of operation): deep wound infection ¿ required surgical intervention, ulcer/gastrointestinal complication, pain, back pain, shortness of breath.Total hip adverse events (all occurring within 60 days of operation): deep wound infection ¿ required surgical intervention, bone fracture ¿ required surgical intervention, dislocation ¿ required surgical intervention, pain, urinary tract infection, severe constipation, back pain, shortness of breath.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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