Article entitled ¿tuberosity union in patients with proximal humerus fractures treated with reverse shoulder arthroplasty: a technical note and exploratory analysis¿ written by florian hess, laurent bohnert, laurenz jaberg, joellen welter, hans-christoph pape, and andrea sireus published by international orthopaedics on september 22, 2020 was reviewed.The articles purpose was to describe this refixation technique, and present short-term clinical and radiological outcomes from its use in 30 patients.30 patients were implanted with global unite fracture reverse system between (b)(6) 2018-(b)(6) 2019.All fractures were fixated with permatape sutures.At final follow up (12 months) no complications such as infection, instability, implant loosening, or a need for revision surgery were detected.Adverse events involving depuy synthes products: 2 patients had a uti (treated with antibiotics).1 patient had post op pneumonia (treated with antibiotics).1 patient developed a post-op hematoma after early post-op substitution of anticoagulants to treat afib.Hematoma was treated conservatively.3 patients were noted to have scapular notching (no treatment indicated).27/30 patients had adequate tuberosity healing and favorable clinical outcomes.3 additional treatment was noted for the 3 patients without adequate healing.
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Product complaint # (b)(4).Investigation summary - the device associated with this reported event was not returned.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.
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