Stryker LFit V40 Femoral Head Lawsuit Update: Pretrial proceedings for lawsuits around the United States have been centralized in the District of Massachusetts under 28 U.S.C. § 1407. This means that each person alleging harm from this product maintains an individual case, but all of the evidence gathering and other pretrial proceedings are done collectively by all of the people suing the company. This is called multidistrict litigation (MDL). It is not a class-action lawsuit. You can contact our law firm for more information regarding this: 1-888-377-8900 (toll-free).
Find out if you have a Lawsuit against Stryer for Injury from an LFit Femoral Head
Attorney David Szerlag is investigating claims of hip replacement failure involving a Stryker Accolade TMZF stem and an LFit™ Anatomic CoCr V40™ Femoral Head. These products are made by Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics.
If you have had revision surgery because your hip replacement implants failed, you may have the right to sue for compensation. We are looking at cases involving either of the following:
- Cobalt and chromium poisoning referred to as metallosis; and
- Spontaneous dissociation of the modular femoral head.
Patients and their families can contact David for a free consultation.
Cobalt and Chromium Poisoning
Recent medical research looked at cases where patients needed revision hip surgery because corrosion at the head-neck juncture had released damaging amounts of cobalt and chromium into the surrounding tissue (Manthe, et al. “Trunnion Corrosion Causing Failure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components”):
- “Black debris at the head-neck junction was identified in all patients.”
- All of the patients involved in this study had increased levels of cobalt and chromium, primarily cobalt.
- “Synovial tissue hypertrophy [joint swelling] and necrotic periarticular debris [dead tissue around the joint] were seen in all patients.”
- One had a psuedotumer [non-cancerous growth that causes severe pain].
Tissue and bone damage in the patients was caused by cobalt and chromium poisoning (metallosis), according to the researchers. The metallosis was the result of corrosion and fretting/micro-movement at the junction of the femoral head (containing cobalt and chromium) and the trunnion of the stem (made with titanium), called the neck, which released cobalt and chromium ions into the surrounding tissue:
“Corrosion at the tapered head-neck junction of a monolithic titanium alloy femoral component [like the Stryker Accolade] and modular cobalt-chromium femoral head can result in elevated serum metal ion levels and adverse local tissue reaction,” which can lead to failure of the total hip replacement (total hip arthroplasy).
The wear at the femoral head-neck interface is called trunnionosis, and it can cause a total hip replacement failure. In these cases, the trunnionosis was related to the release of metal ions (cobalt and chromium) or particulate debris from the implant components. The release of cobalt and chromium can cause necrosis (tissue death), vasculitis (inflammation of blood vessels), and pseudotumors (non-cancerous growths).
Spontaneous Dissociation of Femoral Head from Accolade TMZF Stem
Hip replacements involve a head, which looks like part of a ball and a stem. The ball sits on the stem, which allows the patient to have a natural hip movement. Spontaneous dissociation is when the head comes off of the stem for a reason other than trauma. When this happens, surgery is needed to correct the problem.
One study looked at three cases of spontaneous dissociation, each involving a Stryker Accolade TMZF stem. In all three patients, revision surgery found corrosion, severe wear and deformation of the trunnion of the stem (Talmo, et al. “Spontaneous modular femoral head dissociation complicating total hip arthroplasty”).
Stryker Recall
On August 29, 2016, Stryker sent a letter to orthopedic surgeons regarding a recall of certain Stryker LFit V40 Femoral Heads used in hip replacement procedures. Anyone adversely affected by a recalled Stryker LFit product can contact our law firm about a lawsuit seeking compensation for pain and suffering, surgery and hospital bills, lost wages due to time unable to work, and other damages. Recovery time for revision surgery can be longer than the initial total hip replacement surgery, and the outcome may not be as favorable.
The recall was issued because “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.” The taper lock is the part of the implant that connects the femoral head to the femoral neck.”
According to the recall letter, a taper lock failure could result in the following harm to the patient:
- loss of mobility
- pain
- inflammation
- adverse local tissue reaction
- dislocation
- joint instability
- broken bones around the components
- leg length discrepancy
- need for revision surgery
The products involved are as follows:
Item number | Head diameter | Offset |
---|---|---|
6260-9-236 | 36 mm | +5 |
6260-9-240 | 40 mm | +4 |
6260-9-244 | 44 mm | +4 |
6260-9-340 | 40 mm | +8 |
6260-9-344 | 44 mm | +8 |
6260-9-440 | 40 mm | +12 |
6260-9-444 | 44 mm | +12 |
Sources
Manthe, Megan, et al. “Trunnion Corrosion causing Failure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components.” Reconstructive Review 6.1 (2016)
Talmo, Carl T., et al. “Spontaneous modular femoral head dissociation complicating total hip arthroplasty.” Orthopedics 37.6 (2014): e592-e595.
Stryker. Urgent Medical Device Recall Notification. August 29, 2016.