[1438]
Patient was originally treated for a fracture in june 1987 and had a total hip implant. A revision was performed in august 1988. On october 25, 1992 patient was diagnosed as fractured acetabular component left hip arthoiplasty. The patient is extremely active and lifts heavy objects. During week prior to admission, patient felt a snap and experienced pain in left hip. X-rays of left hip revealed a cemented left totalt hip arthroplasty with the femoral component being solidly in place. The acetabular component has a metal backing wihich is solidly in place against acetabular fossa. The polyethylene space has become distorted and the femoral head had now come into contact with the acetabular shell. It also shows sthe polyethylene portions of the acetabular component fracture. Visual examination of the acetabular liner shows a thin (1/16") approx. 1/2" long x 3/16" wide rugged chip fractured from the inside lower portion of the liner. Ecri has stated that they can do a thorough evaluation of this device and could only recommend clemson university as a third party investigator. Device may be sent to manufacturer for evaluationinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5