Purpose The introduction of patient-specific instruments (PSI) for guiding bone cuts could increase the incidence of malalignment in primary total knee arthroplasty. The purpose of this study was to assess the agreement between one type of patient-specific instrumentation (Zimmer PSI) and the pre-operative plan with respect to bone cuts and component alignment during TKR using imageless computer navigation.MethodsA consecutive series of 30 femoral and tibial guides were assessed in-theatre by the same surgeon using computer navigation. Following surgical exposure, the PSI cutting guides were placed on the joint surface and alignment assessed using the navigation tracker. The difference between in-theatre data and the pre-operative plan was recorded and analysed.ResultsThe error between in-theatre measurements and pre-operative plan for the femoral and tibial components exceeded 3° for 3 and 17 % of the sample, respectively, while the error for total coronal alignment exceeded 3° for 27 % of the sample.ConclusionThe present results indicate that alignment with Zimmer PSI cutting blocks, assessed by imageless navigation, does not match the pre-operative plan in a proportion of cases. To prevent unnecessary increases in the incidence of malalignment in primary TKR, it is recommended that these devices should not be used without objective verification of alignment, either in real-time or with post-operative imaging. Further work is required to identify the source of discrepancies and validate these devices prior to routine use.Level of evidenceII.