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It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and bhr cup were removed.The anthology stem remained implanted.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.An mri report showed a large fluid collection around right hip consistent with pseudomass/pseudotumor.The intraoperative report indicated metal debris noted at the junction the trunnion.The acetabular cup was loose.The operative report indicated tissue samples were sent for culture, however no findings were reported.Although the intraoperative findings of metal debris, loosening, trunnionosis and metallic fluid are consistent with findings associated with metallosis, without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported metallosis, pseudotumor and acetabular cup loosening cannot be confirmed, and 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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