The root cause for the failure was unable to be definitively determined.The distal femur axial pin was found to have been manufactured without issue and was conforming during all inspection.The tibial hinge component and the distal femur implant were also found to not have any issues during manufacturing and were also conforming during all inspection.There was no report that the surgeon deviated from the recommended surgical technique.However, based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
|