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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The literature article entitled, "delta xtend reverse shoulder arthroplasty ¿ results at a minimum of five years" written by craig m.Ball published by shoulder and elbow accepted by publisher 29 january 2019 was reviewed.The article's purpose was to review the clinical and radiographic outcomes of the delta xtend reverse shoulder arthroplasty at a minimum of five years.Data was compiled from 57 patients (59 shoulders) all implanted with delta xtend either uncemented modular stems or cemented monobloc between june 2007 and june 2012.Cement manufacturer is not identified.Figure 3 provides a radiographic image of a longer stem that replaced a primary delta xtend that was loose and associated with a fracture sequelae and proximal humeral bone loss.Adverse events: fracture sequelae with loose stem and proximal humeral bone loss (treated by revision to a longer stem, intraoperative calcar fracture (no treatment specified), axillary nerve palsy (listed a complication without recovery), minor transient neuropraxia of the thumb and index finger (resolved completely within 3-6 months and had no effect on clinical outcome), periprosthetic fracture of the metaglene post a fall (treated by revision), symptomatic notching with pain (treated by revision of glenosphere and liner exchange), stem subsidence (treatment not specified), cortical resorption (treatment not specified).
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