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Dangers of the Stryker LFIT Anatomic CoCr V40 Femoral Heads

The Stryker LFIT Anatomic CoCr V40 femoral heads were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural biomechanics, providing a more natural performance with increased range of motion and reduced dislocation incidents. The device received FDA approval for various LFIT femoral head components in April 2001 and July 2002, according to rigorous analysis.

However, these products have recently experienced complications in patients, resulting in various recalls.

Recalls

According to the FDA (Recall ID 75246), Stryker officially recalled this device in the United States on November 9, 2016. The recall occurred due to several complaints related to harm caused by something similar to taper lock failure for specific lots of multiple catalog numbers of LFIT femoral heads. Approximately 42,519 units are currently in commerce.

The following parts are included in the recall:

  • Catalog #6260-9-236 – Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 – 7/1/10
  • Catalog #6260-9-240 – Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 – 3/4/11
  • Catalog #6260-9-244 – Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 – 3/4/11
  • Catalog #6260-9-340 – Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 – 3/4/11
  • Catalog #6260-9-440 – Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 – 3/4/11
  • Catalog #6260-9-344 – Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 – 3/4/11
  • Catalog #6260-9-444 – Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 – 3/4/11

In Canada, there were two recalls for this device. The first recall occurred on September 10, 2015, after Stryker received customer complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. The second recall occurred on August 24, 2016 due to taper lock failure for specific femoral heads manufactured before 2011.

In Australia, the Department of Health published a “hazard alert” due to specific Stryker LFIT V40 femoral heads. Taper lock failures may relate to possible taper lock interface inconsistency.

Potential hazards associated with taper lock failures include:

  • Disassociation of the femoral head from the hip stem
  • Fractured hip stem trunnion
  • Increased metallic debris
  • Insufficient range of movement
  • Insufficient soft tissue movement
  • Insufficient soft tension
  • Noise
  • Loss of implant
  • Increased wear debris (polymetric)
  • Implant construct with shortened neck length
  • Bone fixation strength

For more information or if you suffered an injury due to this defective product, contact our Midland personal injury lawyer at Dean Law Firm today.

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