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, cup 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 hemi head.Similar complaints have been identified for the cup 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.No further actions are required at this time.The available medical documents were reviewed.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 25° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the corrosion and discolored fluid noted intraoperatively.It was reported that the metal ion levels were elevated and ct showed osteolysis; however, neither the levels, lab reports, nor medical imaging were provided.Without the supporting lab/pathology results or relevant imaging, the root cause of the reported elevated metal ions, corrosion, osteolysis, and discolored fluid 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 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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.
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