| Reason for the Action |
The manufacturer, Corin Limited UK, has identified that the surface roughness of the device is out of specification. The potential sequence of events for excessive surface roughness could be premature wear of the plastic component, which could result in joint instability, poor joint mechanics and osteolysis leading to implant loosening and revision.
After implantation, all tibial inserts initially experience a bedding-in wear phase, during which the surface asperities of the articulating surface of the insert are removed or flattened and the joint experiences an increasing rate of wear. After this initial bedding-in period, the wear rate of the replaced joint levels out.
The discrepancy in the tibial insert articulating surface finish for this batch may result in a slight increase of the wear seen during the bedding-in phase, however this will likely level to the same rate after the bedding-in period, and over the lifetime of the device is expected not to cause a significant difference in overall wear rate for the joint.
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