It was reported that a revision surgery was performed on the patient right hip on (b)(6) 2019.The revision surgery was performed due to pain, loosening of right total hip replacement, heterotopic ossification, pseudotumor for metal on metal debris, contracture, compression of sciatic nerve, complex wound.The patient outcome is unknown.
|
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.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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The root cause for the loosening, heterotopic ossification, contracture, and compression of sciatic nerve cannot be definitively determined with the information provided.However, heterotopic ossification, can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.It has been reported as a cause for the compression of the sciatic nerve in some cases.The information provided, of a pseudotumor may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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.
|