Us legal mdl - it was reported that a revision surgery was performed on the patient's left hip due to pain, limited mobility, metallosis, elevated metal ion levels.The patient outcome is unknown.
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It was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and sleeve were removed.The stem remained implanted.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 bhr cup, hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup and hemi head.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The bhr cup and sleeve involved met manufacturing specifications at the time of production.Non-conformance was identified for the castings inspection procedure paperwork for the hemi head.However, all supporting documents confirm that this was an acceptable product when released.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 and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels and metallosis in the surrounding tissue may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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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