Retrieval analysis of a ProDisc-L total disc replacement

J Spinal Disord Tech. 2009 Jun;22(4):290-6. doi: 10.1097/BSD.0b013e31816dd2b6.

Abstract

Study design: We retrieved a functioning ProDisc-L total disc replacement and associated tissues at 16 months of service life.

Objective: To analyze a previously unreported mode of implant malpositioning, wear mechanisms, and polyethylene locking mechanism, and to study retrieved periprosthetic tissues.

Summary of background data: The clinical performance of polyethylene in the context of total disc replacements remains poorly understood. In the ProDisc-L, the polyethylene core is fixed to the inferior metal endplate through a mechanical interference locking mechanism similar to those used in tibial total knee components. This case represents the third report of an explanted ProDisc-L prosthesis, and the first reported case of posterior malpositioning with this device.

Methods: The implant was removed via a transperitoneal approach. Its polyethylene core was evaluated for burnishing, fracture, third-body abrasion, and permanent deformation. An identical, never-implanted set of polyethylene and endplate components served as controls for the microscopic evaluation of wear. Two tissue samples were collected from a region adjacent to the failed implant to evaluate tissue morphology and inflammation. Hematoxylin and eosin-stained tissue sections were also evaluated for the presence of polyethylene debris by polarized light microscopy.

Results: The implant was removed without serious incident, although there were incidental venotomies. The patient went on to solid arthrodesis. We found minimal wear, oxidation, and periprosthetic tissue reaction, as might be expected given the short-term duration of implantation and its reason for revision. No evidence was found of malfunction or improper deployment of the locking mechanism. Burnishing seemed to be the result of short-term impingement. Some areas of the tissue matrix showed evidence of early cell degeneration, and some of these areas contained polyethylene particles identified by polarized light microscopy.

Conclusions: A larger series of implant retrievals will be needed to investigate possible wear and the biologic response to increased particle generation.

Publication types

  • Case Reports
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Device Removal
  • Equipment Failure Analysis
  • Female
  • Humans
  • Intervertebral Disc Displacement / complications*
  • Intervertebral Disc Displacement / surgery*
  • Joint Prosthesis*
  • Low Back Pain / etiology*
  • Low Back Pain / surgery*
  • Treatment Outcome
  • Young Adult