(b)(4).The reported event was able to be confirmed by visual inspection of the patella, which exhibited signs of being implanted and the post fractured off.A review of the device history records was unable to be performed as lot number was not provided.Medical records and radiographs were provided and reviewed by a hcp.Review of the available records identified a dislodged patellar hardware component which is subluxed inferiorly by approximately half the patella width.The patella hardware is also slightly tilted with the proximal portion positioned posteriorly and the inferior portion tilted anteriorly.This results in likely metal on metal contact between the patella and femoral component.There is small joint effusion.A definitive root cause was unable to be determined.Concomitant medical devices: unknown tibial component catalog #: ni lot #: ni, unknown femoral component catalog #: ni lot #: ni, unknown articular surface catalog #: ni lot #: ni.
|