It was reported that a revision surgery was performed on right hip due to metallosis and metal debris.During the revision the bhr head and bhr cup were removed.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.According to the provided revision report, the patient had increasing pain and x-rays showed failure of fixation and migration of the femoral component.During the revision, a small amount of clear yellow synovial fluid was seen and sent for analysis.Within the capsule "metallosis tissue staining" was seen and samples sent for pathological analysis.The femoral component was grossly loose and some osteonecrosis at the proximal femoral bone.The cup was in approximately 35° of adduction and 40° of forward version.Review of the provided implantation report did not provide any information that could explain or have contributed to the reasons for this revision.Therefore, it appears that the cup migrated and was not implanted in this position.As no results from the mentioned pathological/microbiological analysis was provided, the nature of the reported loosening, fluid, tissue staining remains unclear.Furthermore, the reason for the loosening, migration, remain unclear.Without the device available for analysis it remains unclear whether the reported loosening or cup position caused wear or edge-loading.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.
|