We are currently in the process of retrieving further information to perform investigation.We will provide a follow up report upon completion.This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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Optimized ortho launched an investigation into this event.No complaint devices were returned to optimized ortho by the customer.Thus, the device history were investigated which included reviewing ops processes, ops acetabular and femoral guides, and pre and post operative imaging of the patient.All manufacturing steps of implant positioning and report generation were reviewed.All operations were completed correctly according to the work instructions.No deficiency was found with any of the ops related process or ops acetabular and femoral guides.Dislocation after a total hip arthroplasty (tha) is influenced by multiple factors.These include the positioning of the acetabular component, the position of the femoral component, the anatomy of the patient, and the lifestyle of the patient post operation.As such, there are multiple factors that may have contributed to the dislocation which are outside the scope of this investigation.Therefore the case is now considered closed.This report is filed with the fda due to an event experienced with a device that is same/similar to those placed on the market in the usa, however, this event occurred outside of the usa.Please note: the submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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