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Stryker Hip Implant LFIT V40 Femoral Head Recall

Stryker Orthopaedic’s LFIT V40 Femoral Heads are utilized in a number of the company’s modular hip replacement systems. In September 2016, Australian medical device regulators issued a Hazard Alert for certain sizes of LFIT Anatomic CoCr V40 Femoral Heads manufactured before 2011, after Stryker received an unusually high number of complaints regarding taper lock failure. It is unclear if this issue will prompt Stryker to announce an LFIT Anatomic CoCr V40 Femoral Head recall for the components named in the Australian alert.

BREAKING NEWS: Stryker LFIT Femoral Head Litigation

• April 2017: The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to centralize all federally-filed product liability claims related to Stryker’s LFIT Anatomic CoCr V40 Femoral Head recall. According to an Order dated April 5^th, the federal docket will be transferred to the U.S. District Court, District of Massachusetts, in order to undergo coordinated pretrial proceedings. Read More
• February 2017: A Hearing Session Order dated February 14th indicates that the U.S. Judicial Panel on Multidistrict Litigation will hear Oral Arguments regarding the consolidation of all Stryker LFIT Femoral Head lawsuits on March 30th in Phoenix, Arizona. Read More
• January 2017: New Jersey plaintiffs pursuing lawsuits involving Stryker’s LFIT Anatomic Cobalt Chromium V40 femoral heads have asked the Multi-County Litigation Center to consolidate the state’s docket before a single judge in Bergen County Superior Court. A letter from plaintiffs dated January 24th notes that 86 cases involving LFIT V40 femoral heads are already pending in Bergen County, while the pace of filings has increased. Read More
• January 2017: Plaintiffs pursuing Stryker hip replacement lawsuits for injuries allegedly related to certain LFIT Anatomic CoCr V40 Femoral Heads are seeking to have all such federal claims centralized in a single U.S. District Court for the purposes of coordinated pretrial proceedings. According to a Petition filed with JPML  on January 13th, at least six Stryker hip lawsuits involving LFIT V40 components are pending in federal courts around the U.S.  However, plaintiffs contend that the litigation has the potential to include thousands of similar claims. Read More

What are Stryker’s LFIT Anatomic CoCr V40 Femoral Heads Used For?

Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are made of a cobalt and chromium alloy and are used in combination with a number of modular hip implants, including:

• Accolade TMZF
• Accolade 2 Stems
• Meridian Stems
• Citation Stems

The LFIT Anatomic CoCr Femoral Heads were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement. Stryker promises that these devices will enhance hip stability, minimize dislocation, and maximize range of motion.

Litigation Involving Stryker LFIT V40 Femoral Heads

In 2014, Law360.com reported that Stryker had been named a defendant in at least five hip replacement lawsuits involving the Accolade TMZF hip stem used in combination with the LFIT Anatomic V40 Femoral Head. The complaints, which had all been filed in New Jersey’s Bergen County Superior Court, alleged that the titanium material of the hip stem would not maintain structural integrity when used in combination with the chromium/cobalt femoral heads. Plaintiffs claim that this may result in fretting and corrosion that releases toxic metal ions into recipients’ bodies, causing severe and permanent destruction of bone and tissue.

Australia Hazard Alert

In September 2016, the Australian Therapeutic Goods Administration (TGA), in consultation with Stryker, issued a Hazard Alert pertaining to certain lots and sizes of LFIT Anatomic CoCr V40 Femoral Heads. According to the notice, some devices manufactured before 2011 had been associated with a higher-than expected rate of taper lock failures. The taper lock is the part of the hip implant that connects the femoral head to the femoral neck.

Failure of the taper lock could result in the following serious complications:

• Loss of mobility
• Pain
• Inflammation
• Adverse local tissue reaction
• Dislocation
• Joint instability
• Broken bones around the components
• Leg length discrepancy
• Need for revision surgery

Components named in the Australian alert included:

• Catalog #6260-9-236; Head diameter 36mm; Offset +5
• Catalog #6260-9-240; Head diameter 40mm; Offset +4
• Catalog #6260-9-244; Head diameter 44mm; Offset +4
• Catalog #6260-9-340; Head diameter 40mm; Offset +8
• Catalog #6260·9-440; Head diameter 40mm; Offset +12
• Catalog #6260-9-344; Head diameter 44mm; Offset +8
• Catalog #6260-9-444; Head diameter 44mm; Offset +12

Patients in Australia have been advised to consult their implanting surgeon if they experience unexpected pain, loss of mobility, inflammation, instability, or other issues related to the implant.

Health Canada Announces Stryker Hip Recall for LFit V40 Femoral Heads

A month before the Austrialian alert was issued, Health Canada announced recall for he same LFit V40 Femoral Heads. Becker’s Spine Review has also reported  that the FDA’s MAUDE database lists more than 100 adverse effects associated with the LFIT Anatomic CoCr V40 head specifically, including some that cite pain and limb shortening. Read More

Attorneys Reviewing Stryker Hip Lawsuits

Recipients of these devices may be able to to pursue legal action, even in the absence of a Stryker LFIT V40 Femoral Head recall, if they experienced complications allegedly related to taper lock failure. To obtain a free, no-obligation review of your potential Stryker hip lawsuit, please contact Bernstein Liebhard LLP today, by calling (888) 994-5118.