Correction d1, d9/h3, h6 device code, results code, method code, conclusion code.The reported event (revision) could be confirmed, since the device was explanted and sent back for evaluation.The device inspection revealed the following: examination of the returned tibial tray finds very little osseointegration.There are remnants of biological material indicating the device had been in-vivo.Scratches and deformation are seen on the inferior side of the tray and are consistent with removal techniques.The width, length, and other key dimensions of the tray were found to be within specification.Medical affairs was consulted on this case.Regarding the imaging and device inspection relating to the allegation of loosening, it was noted, "the ct-slices and the tilt of the tibial component, together with the retrieved implant confirm loosening altogether" and ".The little bone ingrowth into the porous coating, caused a lack of osteointegration and therefor heightened the chance of loosening and device migration." however, due to the lack of demographic and clinical information, a definitive root cause cannot be determined.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The current instructions for use states: "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.Prosthetic components can loosen or migrate due to trauma or loss of fixation." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided , the case will be reassessed.
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