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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Article entitled "comparative study of 145 onlay curved stem versus 155 inlay straight stem reverse shoulder arthroplasty: clinical and radiographic results with a minimum 2-year follow-up" written by matthew c.Giordano, md, katia corona, md, brent j.Morris, md, fabrizio mocini, md, luca saturnino, md, and simone cerciello, md published in journal of shoulder and elbow surgery in 2022 was reviewed.The aim of the present study was to compare clinical and radiographic results of a new curved 145 onlay design with a traditional straight 155 inlay design in patients undergoing primary rsa.Study included 76 patients who underwent an rsa between march 2013 to may 2019.42 patients were implanted with a long straight inlay stem with a 155 nsa (delta xtend rsa system).30/42 patient had cemented stems ¿ cement mfg is unknown.Adverse events related to delta xtend
1 patient had a local infection, which required surgical d debridement.1 dislocation, which required revision surgery after 2 months.The 10 patients had scapular notching per radiographs: no treatment noted.3 patients had cortical thinning per radiographs: no treatment noted.7 patients had calcar osteolysis per radiographs: no treatment noted.Radiolucency (1 for humeral and 6 for glenoid): no confirmed through revision.
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