The literature article entitled, "reverse shoulder arthroplasty for rheumatoid arthritis since the introduction of disease-modifying drugs" written by devin r.Mangold, eric r.Wagner, robert h.Cofield, joaquin sanchez-sotelo, and john w.Sperling published by international orthopaedics and published online 26 july 2019 was reviewed.The article's purpose was to retrospectively review clinical and radiographic outcomes of patients who underwent reverse shoulder arthroplasty for rheumatoid arthritis and other inflammatory arthropathies and provide a comprehensive analysis to identify factors that may alter patient outcomes.Data was compiled form 75 patients who received primary rsas between 2006 to 2013 and had at least a two year follow up.Depuy products were listed amongst non-depuy products within the study.Article reports some humeral components were cemented but does not specify the manufacturer of the cement, nor does it identify which manufacturer implants were cemented other than anatomical location of humerus.The article also does not identify specific products relating to specific adverse events.All figures provide radiographic images for illustrative purposes and does not identify products or manufacturers of captured implants.Depuy product: delta iii and delta xtend constructs.Generalized adverse events: intraoperative humeral fracture occurring during implantation (treatment not specified) post op humeral displaced fracture involving "press-fit humeral component" (treated by revision).Deep periprosthetic infection (treated with surgical irrigation and debridement and components retained).Glenoid component loosening (both patients had minimal symptoms and did not wish to undergo revision surgery - no treatment, no further details provided on "loosening") radiographic detection of scapular notching (no treatment provided).
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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.
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