Us legal.It was reported that the patient underwent a medically indicated revision of the bhr-tha hybrid system right hip on (b)(6) 2019 due to pain, limited mobility and elevated ion levels.Among the intraoperative findings there was dark brown, dark gray fluid, evidence of metallosis and corrosion between the femoral head and the trunnion.The patient outcome is unknown.
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H3, h6: it was reported that right 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.As no device batch numbers were provided for investigation, a manufacturing record, complaint history and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain, limited mobility, elevated ion levels and metallosis) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.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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