[18446217]
Patient experience painful total knee with polymer. Revision performed january 23, 1992. On pathological examination, the metallic femoral component measured 5. 3 x 4. 6 cm. The metallic articular surface was smooth and shiny. The high density polyethylene and metallic patellar component measured 3. 5 x 3. 0 x 1. 0 cm. The articular surface was focally roughened. The high density polyethelene and metallic total component measured 5. 8 x 4. 0 x2. 0 cm. The articular surface was markedly worn. The pathological diagnosis was chronic proliferative synovitis with foreign body reactioninvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: material degradation/deterioration, other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5