Stryker LFIT V40

STRYKER LFIT™ Anatomic CoCr V40™ Femoral Head

URGENT RECALL:

STRYKER LFIT™ Anatomic CoCr V40™ Femoral Head

In August 2016, recall notifications/safety alerts were issued in Canada, Australia and the United States involving certain sizes and lot numbers of the LFIT V40 femoral head – a medical device designed and manufactured by Howmedica Osteonics Corp. (a subsidiary of Stryker Corporation). In its August 29, 2016 letter to orthopedic surgeons, Stryker explained that the LFIT V40 Head was recalled because of a high incidence of “taper lock failure”. Stryker identified various potential hazards associated with LFIT V40 taper lock failure, including metallosis (elevated cobalt or chromium in the blood) which can result in an adverse local tissue reaction (“ALTR”), tissue destruction, and device failure, and require additional surgery to revise or replace the hip implants.

This is not the first time Stryker has initiated a recall of hip components with a higher than expected rate of failure. In June 2012, Stryker recalled its Rejuvenate and ABGII modular femoral stems because of a high early failure rate, resulting in revision surgeries to replace the defective devices. Meshbesher & Spence represented hundreds of patients injured by the Rejuvenate and ABGII stems in lawsuits against Stryker, and helped craft a global settlement requiring Stryker to pay nearly $2 billion to injured patients.

 

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What Injuries are Associated with the LFIT V40 Femoral Head?

  • Disassociation of the femoral head from the hip stem
  • Hip stem fractures
  • Metallosis (cobalt and/or chromium poisoning)
  • Inflammation and pain
  • Loss of implant/bone fixation strength
  • Damage to the abductor muscle complex
  • Adverse Local Tissue Reaction
  • Need for revision surgery to replace failed components

What’s Wrong with the LFIT V40 Femoral Head?

A typical total hip replacement system consists of four separate components: 1) a femoral stem; 2) a femoral head; 3) a liner; and 4) an acetabular shell. A Morse taper (a cone-within-a-cone) is used to mate the LFIT V40 Head with the femoral stem. The bore (female portion) of the LFIT V40 Head is placed onto the tapered trunnion (male portion) of the femoral stem and impacted by the surgeon using a hammer. The stresses created by compression of the wall of the bore by the trunnion results in a cold-welding or locking of the head/stem taper interface (i.e. taper lock). Failure of the taper lock or cold-weld between the LFIT V40 Head bore and the female stem trunnion allows micro-motion of the components and promotes corrosion and fretting.

Which Particular LFIT V40 Heads Were Recalled by Stryker?

Stryker has identified the following LFIT V40 femoral heads manufactured prior to 2011 as included in its August 2016 recall:

Implant Item No. Head Diameter Offset
6260-9-236 36mm +5
6260-9-240 40mm +4
6260-9-244 44mm +4
6260-9-340 40mm +8
6260-9-344 44mm +8
6260-9-440 40mm +12
6260-9-444 44mm +12

For the specific Lot Numbers included in the recall, click here.

Was an LFIT V40 Used During My Hip Replacement Surgery?

Whenever a medical device is implanted during surgery, a detachable sticker is removed from the device packaging and placed in the patient’s medical record. This sticker has a bar code and identifies the make, model, and serial number of the enclosed parts. This product identification label will tell you exactly what type of components were implanted during your hip replacement surgery. Meshbesher & Spence will obtain these product identification stickers on your behalf from the implanting hospital free of charge.

What Should I do if I Have an LFIT V40 Femoral Head?

Unfortunately, Stryker’s Recall Notification does not provide any instructions for follow-up testing and treatment for patients implanted with the LFIT V40 femoral heads. However, we recommend having a simple, inexpensive blood test to check cobalt and chromium levels. If your levels are elevated, this is a sign that your hip is failing. Cobalt and chromium is measured in “parts per billion” or ppb. Normal cobalt and chromium are at levels less than 1 ppb. Many people with LFIT V40 heads have been found to have cobalt and chromium many times higher than normal in their blood.

If you have elevated cobalt and chromium in your blood, your surgeon will likely order a Metal Artifact Reduction Sequence or “MARS” MRI. This is a special type of MRI that is designed to determine whether there is soft tissue damage in your hip or the development of pseudotumors (abnormal pockets of fluid). These soft tissue injuries will not show up on x-rays.

Why Contact Meshbesher & Spence?

Reason 1: Experience. Our mass tort lawyers have been court-appointed leaders in national medical device cases for years. With regard to Stryker hip litigation, Genevieve Zimmerman and Tony Nemo were appointed by United States District Court Judge Donovan Frank (District of Minnesota) in July 2013 to serve as Lead and Liaison Counsel (respectively) in multidistrict litigation involving Stryker’s recalled Rejuvenate and ABGII hip systems. In June 2017, Ashleigh Raso was appointed as Administrative Counsel in the LFIT V40 litigation by United States District Court Judge Indira Talwani (District of Massachusetts). Attorneys Zimmerman, Nemo and Raso are well-versed in the medicine, science, and law involved in the Stryker LFIT V40 litigation.

Reason 2: Commitment. Unlike many firms who make big promises and then refer their cases to other attorneys, Meshbesher & Spence will handle your V40 hip case from beginning to end.

Reason 3: A Track-Record of Success. The lawyers at Meshbesher & Spence have recovered well over $100 million for their drug and medical device clients over the past few years.

If you have suffered injuries as a result of your Stryker V40 Femoral Head hip replacement component, or if you are unsure about the type of device implanted in your hip, contact Meshbesher & Spence today. Your consultation is free and you pay nothing until our Firm recovers fair compensation for you and your family.

STRYKER LFIT V40™ Litigation Team