Stryker Issues New Hip Implant Recall

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Stryker LFIT V39 Femoral Head Recall

By: Marilyn McGoldrick, Esq.

Stryker Corporation has notified physicians and hospitals of an Urgent Medical Device Recall of its LFIT Anatomic Cobalt Chrome V39 femoral heads manufactured before 2011. Stryker received what it called a “higher than expected” number of reports from doctors of taper lock failure.

What is taper lock failure? The taper is the very narrow end of the femoral stem where it connects to the ball of the hip implant. When the taper lock – the connection between the stem and the ball – fails, the hip can become unstable and a number of complications can result. Because the Stryker LFit V39 femoral heads are made of a cobalt chromium alloy, the metal can corrode, releasing cobalt and chromium fragments into the tissue. The corrosion can also result in fractures and loosening of the implant.

Potential Taper Lock Failures Associated with Stryker LFIT V39 Femoral Heads

  • Disassociation of the femoral head from the hip stem. Literally, the hip implant comes apart.
  • Fractured hip stem trunnion
  • Excessive metallic debris
  • Metallosis
  • Insufficient ROM (range of motion)
  • Insufficient soft tissue tension
  • Noise (clicking, grinding, popping, clunking)
  • Loss of implant to bone fixation strength
  • Excessive wear debris
  • Implant construct with a shortened neck length

Patient Complications From Defective Stryker LFIT V39 Femoral Heads

If you have a defective Stryker LFit V39 femoral head as part of your hip implant, you may have experienced the following complications:

  • Adverse local tissue reaction
  • Broken bones around components
  • Dislocation
  • Inflammation
  • Joint instability
  • Leg length discrepancy
  • Loss of mobility
  • Pain
  • Revision surgery necessary

Was Your Stryker Hip Implant Recalled?

Physicians began notifying patients of this recall in September 2016. If you don’t know the implant number, call your doctor’s office. They will have it.

Here are the specific models subject to the recall:
Catalog Number          Head          Diameter Offset
6260-9-236                  36mm                  +5
6260-9-239                 39mm                  +4
6260-9-244                 44mm                  +4
6260-9-339                 39mm                  +8
6260·9-439                 39mm                 +12
6260-9-344                 44mm                  +8
6260-9-444                 44mm                 +12

If you have received notification of this recall, you should consult with an attorney to make sure that your legal rights are properly protected.

What If You Have a Different Stryker Hip Implant?

This is not the first Stryker corporation hip implant component recall. Stryker previously recalled the ABG II and Rejuvenant hip replacements in July of 2012. Those were also metal-on-metal hip implants.

Do I Have a Case?

If you have a defective metal-on-metal hip implant, whether from Stryker Orthopaedics, or those manufactured by Biomet, Johnson & Johnson’s DePuy Orthopaedics, Wright Conserve, or Zimmer Holdings, you may be eligible to file a claim for money damages. You may be compensated for lost income, medical expenses for revision and replacement surgery, damages for pain and suffering, physical injuries, and any other losses you suffered as a result of your defective hip implant.  Contact the Boston law firm of Thornton Law Firm LLP online or call Attorney Marilyn McGoldrick at 1-888-341-1405 for a consultation with a specialist in hip implant litigation. The consultation is free and confidential. We look forward to discussing your potential legal case with you.

Boston Scientific Recalls Cardiology Guidewire After Patient Death

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If you have suffered injury caused by a defective drug or medical device, call 888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.

By: Marilyn McGoldrick, Esq.

Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.

The Rotabator Rotational Atherectomy System is used to surgically remove atherosclerosis from arteries. The device uses a tiny burr rotating at high speed to remove plaque and improve blood flow to the heart. The tip of the device rotates at 190,000 rotations per minute during the procedure.

The recall covers 955 devices distributed in the following states: Arizona (AZ), California (CA), Delaware (DE), Florida (FL), Georgia (GA), Illinois (IL), Louisiana (LA), Maryland (MD), Mississippi (MI), Minnesota (MN), Nebraska (NE), New York (NY), Pennsylvania (PY), South Carolina (SC), Texas (TX), Washington (WA), and Wisconsin (WI). The recalled devices were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.

Boston Scientific sent hospitals an Urgent Medical Device Recall letter in October of 2015 asking them to stop using the device immediately. The FDA announced the Class 1 recall of the device in November.

If you believe you suffered injuries as a result of a faulty Boston Scientific guidewire, contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.

Zimmer M/L Taper Hip Replacement Devices Recalled

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by Marilyn McGoldrick, Esq.

Published on June 20, 2015

Zimmer has announced a voluntary recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks used in hip replacements, because higher than expected amounts of manufacturing residues were left on the devices. Zimmer calls this a “process monitoring failure”; you’d probably call it not cleaning the parts properly before putting them on the market. The FDA announced the Class 1 Recall, the most serious type of recall, as use of the products will cause serious adverse medical consequences or even death. Affected products were manufactured and distributed between March 31, 2015 and April 20, 2015. If you had a hip replaced in 2015, call Thornton Law Firm today at 888-491-9726 for a free evaluation of your potential legal claim, or tell us your story using our secure online form.

The M/L Taper with Kinectiv Technology femoral stems and necks are Tivanium® alloy implants that the surgeon uses to fit the artificial hip to the existing bone. The damaged parts of the femur are removed and replaced with a system of artificial products, which includes the femoral neck – the thinner part of the femur next to the ball of the joint – and the femoral stem, the longer part of the bone tapering down from the femoral neck.

The higher than expected levels of manufacturing residue on the parts may lead to serious health consequences. The FDA warns that patients and doctors should be alert for allergic reactions, pain, infections, or even death after a hip replacement using these recalled Zimmer parts. A second hip replacement surgery – a revision – may be required to remove the defective parts. A hip revision involving the neck and stem is very invasive as the femoral stem must be disconnected from the existing bone to which it was attached during the first surgery.

This is Zimmer’s second Class 1 Recall in the last three months. Zimmer announced in March that it was voluntarily recalling its Zimmer Persona Trabecular Metal Tibial Knee Implant after an unexpectedly high complaint rate of 61% was reported. That device, which was marketed as giving a superior, more accurate fit, actually was loosely fitted, with space between the implant and the bone, leading to swelling, severe pain, tissue damage, bone damage, and possibly revision surgery.

If you or a loved one had a hip replacement using Zimmer M/L Taper femoral necks or stems, and have experienced complications including allergic reactions, pain, infections, revision surgery, or even death, you may have a legal claim against Zimmer. The medical device team at Thornton Law Firm specializes in helping patients nationwide who have been injured by defective medical devices like the Zimmer M/L Taper hip replacement parts. For a free, confidential evaluation of your legal rights, contact us at 888-491-9726 or tell us your story here.

Zimmer Persona Knee Implant Recalled

By Marilyn McGoldrick, Esq.

Published on April 3, 2015

The Zimmer Persona Trabecular Metal Tibial Knee Implant is being voluntarily recalled after an unexpectedly high complaint rate of 61% for all the procedures in which it was used. The recall was announced by the FDA in March in response to complaints of loosening of the implant, as well as asymptomatic radiolucent lines in x-rays, representing space between the implant and the bone.  The recall affects 11,658 patients who received the Zimmer Persona implant. If you or a loved one received a Zimmer Persona implant, contact Thornton Law Firm today for a confidential evaluation of your legal rights.

Zimmer issued Urgent Medical Device Recall letters to affected distributors, hospitals, and surgeons, recalling all of the Persona Knee Implants. The FDA classifies the recall as Class 2, meaning that the defect “may cause temporary or medically reversible adverse health consequences.” These health consequences can be severe. A loosened knee implant may require the patient undergo costly and painful revision surgery. Loosening and radiolucent lines can also cause many other problems. Tissue, joint fluid, and debris from the failing implant can lodge in the spaces between the gaps between the implant and the bone. This can cause swelling, severe pain, tissue damage, and bone damage.

One of the largest medical device manufacturers in the world, Zimmer, Inc. advertised the Persona Knee Implant as “the Personalized Knee System”. It was on the market for 3 years and distributed in 25 states, as well as worldwide. The recall covers all sizes and lots of the Persona Knee Implant.

If you have a Zimmer Persona Knee Implant and have experienced complications including pain, swelling, loosening, disability, or have undergone revision surgery, you may have a legal claim against Zimmer, Inc. Thornton Law Firm’s medical device lawyers specialize in helping patients who have suffered complications after receiving defective devices. Please contact us at 888-341-1405 or tell us your story here. All consultations are free and confidential.

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