It was reported that right hip revision surgery was performed.During the revision, the acetabular cup & oxinium head were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup and this failure will continue to be monitored.A review of the oxinium head could not be completed due to no part/batch information being provided.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Intraoperatively, there was fibrous tissue throughout the region as well as serous fluid within the hip joint which did not appear purulent.The surgeon indicated that there was no blackened tissue or evidence of fibrotic breakdown of the soft tissues.There was some osteolysis around the acetabular cup on the edges, but the cup was well fixed.Fluid and synovium tissue was sent for culture and gram stain however results were not included in the record.The surgeon indicated that there was absolutely zero evidence of stem loosening or evidence of acute inflammation or infection.It cannot be determined to what extent the patients fall had on his pain and clinical status.The reported pain and intraoperative findings of fibrous tissue and serous fluid noted within the hip joint may be consistent with findings associated with chronic inflammation, however, the root cause cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.It was also noted that use of a competitor¿s (biomet) dual mobility bearing was implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers.¿ 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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