It was reported that right hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The cup and stem remained implanted.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, cup, stem and 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 cup and stem.Similar complaints have been identified for the hemi head and sleeve and this will continue to be monitored.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 and surgical technique 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.No further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s previous fall had on his pain and clinical status.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at approximately 25° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the metal debris.The reported pain, elevated metal ions and joint effusion noted on mri along with intraoperative findings of mild metallosis within the capsular tissue as well as significant wear on the trunnion may be consistent with findings associated with metallosis and trunnionosis.However, the root cause of the metallosis and pseudotumor cannot be confirmed and it cannot be concluded that the reported clinical 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.Based on the available information, the proposed root cause is improper loading due to malpositioning of the implant during implantation.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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