Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the shell.A review of the provided medical information by a clinical consultant indicated: "there is evidence of loss of fixation of the acetabular component with revision to a pressfit cup with bone graft and mesh in the supra- acetabular region.There is also evidence of stem fracture through the trunnion.Loss of fixation of a pressfit acetabular component and subsequent fracture of the trunnion of the femoral component is confirmed.The root cause of these mechanical failures cannot be determined from the limited documentation provided." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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