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Related Experiment Video

Updated: May 11, 2026

A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars
05:32

A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars

Published on: August 4, 2018

Manufacturing lot affects polyethylene tibial insert volume, thickness, and surface geometry.

Matthew G Teeter1, Jaques S Milner, Steven J MacDonald

  • 1Division of Orthopaedic Surgery, London Health Sciences Centre, London, ON, Canada. matthew.teeter@lhsc.on.ca

Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine
|May 3, 2013
PubMed
Summary

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Manufacturing variability in new polyethylene tibial inserts can affect joint replacement wear measurements. Using inserts from different lots increases measurement error compared to those from the same lot.

Area of Science:

  • Biomaterials Science
  • Orthopedic Engineering
  • Medical Device Manufacturing

Background:

  • Accurate wear measurements of retrieved joint replacement implants are crucial for assessing device longevity.
  • Reference geometry for wear analysis is often obtained from new, unused implants due to the rarity of pre-implantation scans.
  • Manufacturing variability between new implants can introduce significant errors in wear assessment.

Purpose of the Study:

  • To investigate the impact of manufacturing lot variability on the dimensional accuracy of new polyethylene tibial inserts.
  • To quantify differences in volume, thickness, and surface deviations between inserts from the same and different manufacturing lots.
  • To determine if lot variation introduces confounding errors in wear measurements for joint replacement implants.

Main Methods:

Keywords:
Total knee replacementdimensioning and tolerancesimplant retrieval studymanufacturingmicrocomputed tomography

Related Experiment Videos

Last Updated: May 11, 2026

A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars
05:32

A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars

Published on: August 4, 2018

  • Acquisition of 12 new polyethylene tibial inserts (5 from the same lot, 7 from different lots) of the same model and size.
  • Microcomputed tomography (micro-CT) used to capture the 3D geometry of each tibial insert.
  • Comparative analysis of volume, thickness, and 3D surface deviations between inserts from same vs. different manufacturing lots.

Main Results:

  • Significantly greater variability observed in inserts from different manufacturing lots across all measured parameters.
  • Volume variability was fourfold higher (p < 0.001) in inserts from different lots.
  • Thickness differences reached up to 0.21 mm (p < 0.001) between inserts from different lots.

Conclusions:

  • Manufacturing lot variation is a significant source of error in polyethylene tibial insert measurements.
  • Using new implants from different manufacturing lots as reference geometry can lead to inaccurate wear assessments.
  • Recommendations include averaging geometries from multiple new components across different lots to establish a more reliable reference.