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Stryker LFIT Anatomic CoCr V40 Femoral Head Recall

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On August 29, 2016, Stryker announced a recall of LFIT Anatomic CoCr Heads in Australia.


Stryker LFIT V40 Recall:

Stryker issued an Urgent Medical Device Recall Notification for LFIT Anatomic CoCr V40 Femoral Heads. The notification in Australia occurred on August 29, 2016.

This is not the first recall affecting Stryker hip replacement products. Stryker previously announced major recalls of Stryker Rejuvenate and Stryker ABGII devices. While Stryker has not yet recalled Stryker Accolade devices, it is facing lawsuits regarding Stryker Accolade failures.

Stryker’s Reasons for the Voluntary Recall:

“Stryker has received higher than expected complaints of taper lock failure for specific lots of the following certain sizes of LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011.”

Stryker Products Currently Affected by the Recall:

Below is a list of catalog numbers for the affected Stryker LFIT Anatomic CoCr V40 femoral heads:

Catalog Number Head Diameter Offset
6260-9-236 36mm +5
6260-9-240 40mm +4
6260-9-244 44mm +4
6260-9-340 40mm +8
6260-9-440 40mm +12
6260-9-344 44mm +8
6260-9-444 44mm +12

 

What are the Potential Hazards of Stryker Cobalt and Chromium Femoral Heads?

Stryker listed the following potential hazards from the cobalt and chromium coated LFIT heads:

Side Effects and Potential Hazards:

  • Disassociation of femoral head from hip stem

  • Fractured hip stem trunnion

  • Excessive metallic debris

  • Insufficient range of motion (ROM)

  • Insufficient soft tissue tension

  • Noise

  • Loss of implant, lack of bone fixation strength

  • Excessive wear debris (polymeric)

  • Implant construct with a shortened neck length

What is the Possible Harm to Patients from Stryker LFIT Anatomic CoCr Femoral Heads?

Stryker’s list of potential patient harm from the LFIT Anatomic CoCr V40 femoral heads:

  • Loss of mobility
  • Pain from implant loosening
  • Pain requiring revision
  • Inflammatory response
  • Adverse Local Tissue Reaction (ALTR)
  • Dislocations
  • Joint Instability
  • Prosthetic Fracture
  • Leg Length Discrepancy
  • Revision surgery to alleviate hazardous situations

What Years were these Products on the Market?

Stryker LFIT Anatomic CoCr V40 heads sold prior to 2011 are affected. If you have been implanted with a Stryker device prior to 2011 in the United States you may have been implanted with these recalled femoral head devices.

What is a Taper Lock Failure?

A taper lock failure is a failure of the femoral head at the site of connection to the femoral neck.  Total hip replacement medical devices are designed for multiple components to fit together to form a complete joint. While your original femur bone was a single bone containing the main thigh bone, the femoral neck portion and the femoral head, your total hip replacement consists of multiple pieces put together during the implant operation.

Left to right: femoral stem (with neck), femoral cup, acetabular cup.

Left to right: femoral stem (with neck), femoral cup, acetabular cup.

After a new femoral stem is implanted, a femoral head must be placed onto the neck.  It is at this taper lock that Stryker LFIT Anatomic CoCr V40 heads are failing. Failure can release cobalt or chromium into tissue, produce metallosis or an adverse local tissue reaction, weaken the device to the point of fracture, or cause pain and suffering or loss of mobility. These symptoms can require revision surgery.

Stryker Settlements

Levin Simes has successfully settled cases with Stryker. Stryker agreed to pay billions to settle some Rejuvenate and ABGII claims, including cases represented by Levin Simes. Levin Simes continues to represent those affected by Stryker Rejuvenate, Stryker ABGII, Stryker Accolade and Stryker LFIT V40 devices.

Stryker Lawyer

If you or a loved one has been implanted with a recalled Stryker hip device, please contact the attorneys at Levin Simes immediately. If you would like Levin Simes LLP to investigate your potential claim or lawsuit, please fill out the contact form on this page, email us at info@levinsimes.com, or call us at 1-888-426-4156. We look forward to discussing your case with you.

The full PDF copy of the Stryker Urgent Medical Device Recall Notification is here.