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: doany me, ling k, jeong r, nazemi a, komatsu de, wang ed.Comparison of early range of motion in reverse shoulder arthroplasty based on indication: a single center retrospective review.J shoulder elb arthroplast.2022 jun 14;6:24715492221108283.Doi: 10.1177/24715492221108283.Pmid: 35719846; pmcid: pmc9203724.Objective and methods: authors conducted a retrospective analysis of all reverse shoulder arthroplasties (rsa) (1 jan 2000 thru 31 dec 2018), grouping patients by indication into ¿traumatic¿ and ¿non-traumatic elective¿ groups.The purpose was to compare early active range of motion (arom) of the affected shoulder for both groups.Depuy delta xtend system was used (from 2000 thru 2016), along with a competitor shoulder system (2016-2018).Authors did not break out data into individual patients, such as by case number or age/gender demographics.Results: 367 rsa procedures were performed, 88 for fracture, and 279 for non-traumatic elective indication.Forward elevation and external rotation arom were inferior in the fracture group at all visits in the first two years.Internal rotation arom was equivalent though.Final shoulder survey and patient satisfaction scores were statistically equivalent, though, in the fracture and non-fracture groups.Complications: three revisions occurred in each group.In the fracture group, two were for instability with dislocation, and one was for infection.In the non-fracture group, two were for acromial fractures, and one was for aseptic loosening of the humeral component.Fracture group: 2: shoulders revised to treat instability and dislocation (specifics not provided).1: shoulder was revised to address infection (specifics not provided).Non-fracture group: 2: shoulders revised to address acromial bone fractures (specifics not provided).1: shoulder revised to address aseptic loosening of the humeral component (specifics not provided).
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