[848]
68 year old male 3+ years post left toatal hip replacement with displacement. Readmitted for excision of extensive histiofibrocytic reaction with cypt formation extraction of broken screws & metal shell and inner polyethylene high density liner, replacement of acetabulum & the morse taper 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, other. Results of evaluation: component failure, none or unknown, none or unknown. Conclusion: device failure related to patient condition. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5