It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the sleeve.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that all devices were sterilised.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review could not be performed as hemi heads are no longer sold.As a result, there is no live risk management file to review.The available medical documents were reviewed.The reported drainage, fever, chills, elevated white blood cells, c-reactive protein, erythrocyte sedimentation rate and intraoperative findings of cloudy yellowish fluid may be consistent with infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond infection, 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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