[904]
The ceramic femoral head of a total hip replacement fractured while invivo during normal use. The cermic head was manufactured by feldmuhle and the metal femoral stem was manufactured by the hospital. The acetabular component was manufactured by zimmer. The problem was unanticipated loss of mechanical function of the total hip replacement. The patient was taken to the or and the cermic head fragments were removed, along with the plastic liner of the acetabular com[onent. The ceramic head was replaced by a matellic alloy head and the plastic liner of the acetabular component was replaced. It was determined that the cermic head probably failed by a fatique (multiple loading) fracture mechanism, with the crack initiating on the inside surface of the ceramic head. The articulating surface of the plastic acetabular liner was found tobe severely damaged, consistent with impactionm of the cermic head head fragments and the metal trunnion of the femoral stem, following fracture of the cermic headdevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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, visual examination. Results of evaluation: component failure. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5