Correction h6 device code, result code, clinical sign code.The reported event could be confirmed, since images of scans were provided and do indicate the tibial tray has loosened.The images of scans were reviewed by a medical professional.The following observations were noted, "the presence of osteolysis and radiolucency at the lateral side at the peg of the tibial component, proves loosening.The relative position between the tibial and talar component can only be assessed if we are sure that the ct-scan was made with the ankle in a standardized position.Besides loosening, no other definitive conclusion can be drawn." it was also noted there were bone changes (fibular fracture) at the lateral side, but without additional information no conclusion can be drawn as it could be pre-existing.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.The current instructions for use provided with these devices does state, "with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate matter.Particulate is generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue including third-body wear.Osteolysis can lead to future complications necessitating the removal and replacement of prosthetic components", "dislocation and subluxation of prosthetic components can result from improper positioning and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions" and "prosthetic components can loosen or migrate due to trauma or loss of fixation".More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|