(b)(4).In a review of the labeling and ifu 700-096-060- there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.It is a known complication that a patient¿s age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.The surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) reviewing information regarding use of instrumentation.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues and/or design issues.A revision was attempted and found to be unable to complete due to severe glenoid posterior wear, it was not possible to replace the glenoid and therefore the implant is subluxed posteriorly.There are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.
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As reported by the (b)(6) shoulder study, the patient had a revision due to severe glenoid posterior wear, it was not possible to replace the glenoid and therefore the implant is subluxed posteriorly.The event is not related to the device or to the procedure.Patient original implant date (b)(6) 2009.Patient medical history of hypertension.
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