It was reported that right hip revision surgery was performed due to the presence of a pseudotumor.During the revision, the bhr cup, bhr modular head and modular sleeve 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 known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.This patient underwent a right bhr revision approximately 8 years, 1 month post implantation due to the reported presence of a pseudotumor.Operative reports were provided and translated from french.The revision op report indicates there was a large granuloma, which was removed and revealed corrosion at the head-neck junction.There was also a large medial lesion with significant bone loss at the acetabulum.After extensive debridement, the acetabulum was grafted and the cup was impacted.Cultures were sent to pathology.Stability was tested and was excellent with 50° of internal rotation, at 90° of flexion.Cultures were sent to pathology, however the results were not provided.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported pseudotumor 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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