It was reported that, after a bhr construct had been implanted on (b)(6) 2004, a pseudotumor from residues was formed on the patient.The patient experiences ionemia: the ion levels reported were cobalt 16.2 ppm and chromium 17.71 ppm.A revision surgery was performed on (b)(6) 2020 to address the adverse event.The patient outcome is unknown.
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It was reported that hip revision surgery was performed.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 head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.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.The available medical documents were reviewed.It was reported that a revision surgery was performed on (b)(6) 2020 due to pseudotumor from residues and implant malfunctioning and ionemia.The ion levels reported were cobalt 16.2 ppm and chromium 17.71 ppm.The patient outcome is unknown.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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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