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It was reported that two stage hip revision surgery was performed.During this revision, the acetabular cup and stem were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified, however, these complaints are from the same patient / device.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Sterilization records were reviewed for the stem which confirmed that all devices were sterilized.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.No medical documents have been made available for review, therefore no thorough medical investigation can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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