It was reported that left hip revision surgery was performed.During the revision, the bhr dysplasia cup, dysplasia screws hemi head and modular sleeve were removed.The synergy 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.Elevated cobalt levels, migration, lucency around the cup from radiological studies, loosening, milky material from the hip joint and flocculent debris are consistent with findings associated with metallosis.However, without the radiology images and the return of the implant it cannot be confirmed.Both the loosening of the acetabular component and the loss of mobility were reported post the mva from 2007.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond revision and expected transient post-op convalescence period cannot be determined.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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