A new Stryker hip recall addresses problems with the company’s LFIT Anatomic CoCr V40 femoral heads.

The LFIT femoral heads addressed by the Stryker hip recall have been used in the Stryker Accolade hip implant system.

The Accolade system has already been implicated in a spate of hip implant products liability lawsuits brought by patients who claim to have suffered excessive complications due to the device.

Plaintiffs allege these hip implants have a tendency to shed bits of chromium and cobalt metal into the surrounding tissue.

The loose metal can lead to metal toxicity that can cause pain, broken bones, and necrosis of nearby tissue.

Some patients have allegedly required revision surgery to remove and replace their implants.

Current Stryker Hip Recall Details

According to the Stryker hip recall announcement letter, the recall applies to several different sizes of Stryker LFIT Anatomic CoCr V40 femoral heads.

Stryker says it has received a higher-than-expected number of complaints of taper lock failure related to specific lots of these particular femoral heads.

Stryker says the potential hazards with these femoral heads include:

• Disassociation of femoral head from hip stem
• Fractured hip stem trunnion
• Excessive metallic debris
• Insufficient ROM
• Insufficient soft tissue tension
• Noise
• Loss of implant: bone fixation strength
• Excessive wear debris (polymeric)
• Implant construct with a shortened neck length

The letter says these hazards could lead to one or more of the following harms to the patient:

• User annoyance
• Loss of mobility
• Pain requiring revision
• Inflammatory response
• Adverse local tissue reaction
• Dislocation
• Joint instability
• Revision to alleviate hazardous situation
• Pain associated with implant loosening
• Periprosthetic fracture
• Leg length discrepancy

Stryker’s letter says all the femoral head models at issue are either expired or have already been implanted.

Nevertheless, Stryker has instructed health care providers to check their inventories for any of these femoral heads and quarantine them pending return to Stryker.

Previous Stryker Recalls

This more recent Stryker action follows an earlier recall of the company’s Rejuvenate and ABG II modular hip replacement systems in 2012. This earlier recall was initiated in response to reports that both those hip implant systems were corroding after implantation.

The corrosion, which manifested as fretting at the implant system’s neck joint, allegedly caused substantial death of the surrounding muscle and bone tissue.

In the litigation surrounding Stryker implants, plaintiffs argue these devices are defective by manufacture and design. They allege Stryker failed to adequately test the devices and failed to issue a proper warning to the medical community and the general public about the associated risks of complications.

Plaintiffs in these lawsuits allege suffering many different complications related to their Stryker implants.

Many report symptoms of metallosis, or metal poisoning, that they attribute to the implants’ tendency to shed metal particles. Metallosis can lead to the death of tissue surrounding the implant.

Others have reported mechanical difficulties like instability, looseness or dislocation, potentially leading to loss of mobility or a reduction in their range of motion. Implant failures have allegedly generated symptoms severe enough to require revision surgery.