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Zimmer, Inc.

Zimmer® NexGen® Precoat Pegged Tibial Plate

Product Description

The Zimmer NexGen Precoat Pegged Tibial Plate supports Zimmer’s vision in MIS products and surgical techniques. With its proven clinical history in the Zimmer M/G ® and MG II ® Total Knee Systems, the NexGen Precoat Pegged Tibial Plate is MIS procedure friendly and addresses many issues relating to surgical procedure, implantation, and future revision TKA.

  • Low-profile design simplifies insertion into the small incision/opening required for the Zimmer MIS Quad-Sparing™ Total Knee Procedure
  • Superior stability with minimal bone removal1,2
  • 20 years of excellent clinical results3

The Zimmer NexGen Precoat Pegged Tibial Plate is proven to have excellent long-term clinical results.1 The clinical performance of the NexGen Knee has been followed for 7 years in a prospective, open, multi-center outcomes study consisting of 11,257 patients and 13,250 cases collected by 243 surgeons throughout the United States. Annual radiographic follow-up to 5 years shows the incidence of radiolucency to be very infrequent for pegged tibial plates.

The Zimmer NexGen Precoat Pegged Tibial Plate does not invade/pressurize the tibial IM canal, minimizing the potential for fat emboli. Its tibial preparation approach conserves more bone versus traditional stemmed tibial plates, preserving bone stock if/when revision TKA is needed.

References

  1. Sumner DR, Kienapfel H, Jacobs JJ, et al. Bone ingrowth and wear debris in well-fixed cementless porous-coated tibial components removed from patients. J Arthroplasty. April 1995;10(2):157-167.
  2. Sumner DR, Turner TM, Dawson D, et al. Effect of pegs and screws on bone ingrowth in cementless total knee arthroplasty. Clin Orthop. December 1994;309:150-155.
  3. Miller/Galante, MG II, and NexGen Knees clinical experience in open surgical procedures.

The Zimmer NexGen Precoat Pegged Tibial Plate requires no drilling and broaching of the tibial IM canal. Also, no insertion of a separate provisional tibial plate is necessary (the tibial sizing plate serves double-duty as a provisional).

The low-profile design of the NexGen Precoat Pegged Tibial Plate helps minimize the potential for A/P cortical impingement inside the tibial IM canal and allows surgeons to cut the proximal tibia at the angle of their choice. Keeled plates offer less flexibility on posterior slope cut angles because the keel can more easily impinge/perforate the tibial cortex in the IM canal.

There are no holes in the NexGen Precoat Pegged Tibial Plate, eliminating the possibility of polyethylene cold flow into screw holes.

Indications

This device is indicated for patients with severe knee pain and disability due to:

  • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
  • Collagen disorders, and/or avascular necrosis of the femoral condyle
  • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  • Moderate valgus, varus, or flexion deformities

The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

NexGen Trabecular Metal Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

Individualization of Treatment

Check the appropriate knee implant size matching chart for component matching instructions. Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce implant life.

Use only instruments and provisionals specifically designed for use with these devices to help ensure accurate surgical implantation, soft-tissue balancing, and evaluation of knee function.

Contraindications

Contraindications include:

  • Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
  • Insufficient bone stock on the tibial surface
  • Skeletal immaturity
  • Neuropathic arthropathy
  • Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
  • A stable, painless arthrodesis in a satisfactory functional position
  • Severe instability secondary to the absence of collateral ligament integrity

Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patients using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.