It was reported that right hip revision surgery was performed due to pain, mechanical and aseptic loosening, migration of component, dislocation, leg length discrepancy, loss of mobility and strength.
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It was reported that right hip revision surgery was performed due to severe pain, mechanical loosening, aseptic loosening, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength.The bhr head and bhr cup were removed during surgery.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.This case re-opened due to the receipt of medical documents i.E.Chart sticks, primary operative and revision notes.It was reported five years post implantation of a rtha this forty-five year old female underwent a revision due to severe pain, mechanical loosening, aseptic loosening, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength.Revision intra-operative findings; the acetabular component was found to be well attached without signs of damage to the articulating surface.However, the femoral head component was found to be grossly loose and easily removed by simple bone tamp.The revision report confirms the loosening of the femoral head component.However, without the explant or the request clinical information, the root cause of the loosening of the femoral head cannot be determined nor can it be concluded that the reported pain, migration of component, dislocation, leg length, discrepancy, loss of mobility, and loss of strength were associated with the implanted smith and nephew device.However, the patient's history of avn cannot be ruled out as a contributing factor.The future impact to the patient beyond the revision cannot be concluded.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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