Section h3: the complaint products were not returned for analysis.The condition of revision due to liner disassociation was not confirmed.The design of the shoulder system has been in the field since 2007.The company is aware of 5 other complaint reports involving revised shoulder components due to humeral liner disassociation since 2014.(b)(4).This is considered "very low" according to the frequency of occurrence ranking scale.There has been no patient information provided; therefore, the patient risk/clinical factors cannot be assessed.Section h6: it is noted in labeling and ifu review- that contraindications include: patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.Possible detachment of the coating(s) on the components, potentially leading to increased debris particles.All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.This device is used for treatment not diagnosis.Information about the event and patient have been requested.No information has been provided.Corrected data: d4: serial number (all serial number's were reported incorrectly as they are the implanted devices serial #'s not the explanted.The explanted device serial numbers are unknown).
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