(b)(4).Concomitant medical products: 00584201402 femoral component high flex precoat for cemented use only right medial/left lateral lot# 62605151.00584202210 articular surface size 2 10 mm height femoral size a,b,c,d,e,f,g lot# 61547129.Reported event was confirmed by review of x-rays and provided op notes.Review of the patient's op notes confirms pain a radiographs of the right knee reviewed today reveal moderate joint space narrowing and left knee review reveals varus alignment.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in the associated risk documentation.
|
It was reported that a patient underwent an initial right knee procedure approximately 4 years prior.Approximately one year ago, the patient was treated surgically for pain/throbbing/aching/swelling.Subsequently, the patient was revised due to malpositioned tibial component.
|