On the literature article named "ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up", it was reported that after a sl-plus family stem had been implanted on 1 patient, intraoperative trochanteric fracture occurred in the one patient from the cope group.The event was treated using a trochanteric wire.The patient outcome is unknown.
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H3, h6: the study of van loon et.Al.[1] reports a 10-year study regarding the wear of ceramic-on-ceramic (coe) and ceramic-on-polyethylene (cope) hip pairings.17 cope and 25 coe cases were available for a follow-up.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported that on 1 patient, intraoperative trochanteric fracture occurred.The event was treated using a trochanteric wire.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.The reported failure is stated as a side effect in the ifu.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.(1): (b)(6).
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