At about 2 months after primary, the patient has been revised because of tibial baseplate subsidence.All the components have been revised to a semi-constrained system.The cause of the subsidence is unknown, but the surgeon expressed the opinion that bone quality was poor for a 3d metal implant.In the primary surgery was used the ka surgical technique, while ma has been used during revision surgery.
|
Batch review performed on 29-jan-2024 lot 2115254: 33 items manufactured and released on 27-jan-2022.Expiration date: 2027-01-16.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department two months after primary cementless tka the bone supporting the tibial baseplate collapses and the whole system requires revision.It was revised to a cemented, semi-constrained prosthesis, probably more suitable for the bone quality and the anaytomical configuration of this patient.The cause for this reoperation is to be sought in bone quality and possibly undersizing of the femoral component, we see no reason to suspect a faulty device.
|