It was reported that a revision surgery was performed due to fracture and pain.The device reported is an unspecified stem from anthology hip system.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed at this time.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes could include but are not limited to fit/sizing, traumatic injury or abnormal motion over time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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