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The associated complaint devices were returned and evaluated.A visual examination of the scratching observed on the femoral component and tibial baseplate was likely to contact with each other following disassociation of the insert.The damage observed on the posterior region of the inferior surface of the tibial insert indicated that the insert was not fully engaged in the tibial baseplate.The anterior locking region was undeformed indicating that the insert was not fully engaged in the tibial baseplate.No manufacturing deviations were noted during this investigation.The exact cause of the insert dissociation was not able to be determined.A clinical analysis indicated that details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the lab retrieval analysis, ¿no definite conclusion can be determined as to the exact cause of the insert dissociation¿.However, the findings of both the posterior-inferior tibial insert damage and the lack of anterior locking region deformation indicated the insert was not fully engaged in the tibial baseplate, therefore, cannot be ruled out as the contributing factor to the disassociation.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.
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