The patient underwent a right knee partial arthroplasty.After 4 weeks, the patient reported pain.X-rays demonstrated tibial fracture and anterior subsidence of the tibial component.The implant was revised to a primary cr knee.Review of the device history record indicates that the device was manufactured to specifications.No root cause could be identified for this adverse event.The device was returned to the manufacturer and evaluation is ongoing.Should any additional information change the conclusion on the root cause, a follow-up medical device report will be filed accordingly.
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