In a review of the labeling 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.That 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.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.There is no patient information provided, therefore, it is not possible to make a patient risk/clinical assessment.This device is used for treatment, not diagnosis section(s): no information has been provided.Corrected data: device evaluated by manufacturer - yes- it was reported in follow-up #1.
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The revision reported was likely the result of loosened supporting ligaments, which led to dislocation.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.
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