NuVasive warned doctors to stop implanting the PRECICE System due to biocompatibility concerns, including severe side effects like increased pain and bone changes.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting NuVasive PRECICE System induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: NuVasive Updates Label and Issues Voluntary Recall for PRECICE Implants
On November 30, 2021, NuVasive and the FDA issued updates to inform health care providers of an updated label, which will clarify that the PRECICE implant is only for patients over 18 years old who weigh 50 lbs or more, and that no more than 2 devices should be implanted at a time.
NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed below:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening Device
- Precice Short
- Precice Unyte
FDA Warns Doctors of Biocompatibility Concerns with PRECICE Implants
On July 8, 2021, the FDA sent a Letter to Health Care Providers to warn about potential biocompatibility concerns with NuVasive Specialized Orthopedics’ PRECICE devices, including:
Stainless Steel (Biodur 108)-Based Precice Devices:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
Titanium-Based Precice Devices:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening (IMLL) Device
- Precice Short
- Precice Unyte
What is the Problem?
In February 2021, NuVasive recalled all titanium-based PRECICE devices and pulled all stainless steel-based PRECICE devices off the market in the U.S. due to reports of increased pain and bone changes.
In April 2021, NuVasive announced that it was halting global shipments of all PRECICE devices while they undergo biocompatibility testing.
The root cause of the problems is under investigation. The FDA said it may be related to “corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”
No reports have been linked to the titanium-based devices yet, but the FDA is still not sure if the problem is related to the stainless steel material, or design features in common with all PRECICE implants.
What Side Effects Are Linked to PRECICE Devices?
- Surgery to remove PRECICE implant
- Pain
- Bone changes
- Bone loss (osteolysis)
- Abnormal bone growths
- Corrosion of implant
- Cortical hypertrophy
- And more
What is the PRECICE System?
PRECICE devices are implants that are used to lengthen limbs, shorten or compress limbs, or transport segments of long bones. Patients are implanted with rods that are adjustable with a remote-controlled magnetic mechanism, avoiding the need for more surgeries.
NuVasive PRECICE Recall
On February 20, 2021, NuVasive recalled all titanium-based PRECICE devices due to “reports of pain and bony abnormalities at the interface between the telescoping nail segments,” according to the notice.
Studies Link NuVasive PRECICE Implants With Serious Side Effects
Multiple studies have found dozens of reports of patients who suffered from pain, bone changes, and bad reactions to the PRECICE Stryde Limb Lengthening implants.
In March 2021, a study of 27 patients found extremely high rates of pain and bony changes, leading researchers to conclude: “We recommend removal of Stryde implants as early as possible after consolidation of the regenerate.”
In June 2021, a study of 8 patients who had completed limb-lengthening found that most of them experienced “localized pain and swelling” and bone problems, including “osteolysis and periosteal reaction at the junction of the telescopic nail.”
In June 2021, another study of 23 removed STRYDE implants found that 20 of them (87%) had corrosion at the locking screws and screw holes. They also found “biological material inside the nail … in addition to oozing from the junction of 2 nails during hardware removal.”
References
Rölfing JD, Kold S, Nygaard T, Mikuzis M, Brix M, Faergemann C, Gottliebsen M, Davidsen M, Petruskevicius J, Olesen UK. Pain, osteolysis, and periosteal reaction are associated with the STRYDE limb lengthening nail: a nationwide cross-sectional study. Acta Orthop. 2021 Mar 24:1-6. doi: 10.1080/17453674.2021.1903278. Epub ahead of print. PMID: 33757381.
Iliadis AD, Wright J, Stoddart MT, Goodier WD, Calder P. Early results from a single centre’s experience with the STRYDE nail : a cause for concern? Bone Joint J. 2021 Jun;103-B(6):1168-1172. doi: 10.1302/0301-620X.103B6.BJJ-2020-2165.R1. PMID: 34058877.
Jellesen MS, Lomholt TN, Hansen RQ, Mathiesen T, Gundlach C, Kold S, Nygaard T, Mikuzis M, Olesen UK, Rölfing JD. The STRYDE limb lengthening nail is susceptible to mechanically assisted crevice corrosion: an analysis of 23 retrieved implants. Acta Orthop. 2021 Jun 8:1-7. doi: 10.1080/17453674.2021.1927506.
Do I have a NuVasive PRECICE Lawsuit?
The Schmidt Firm, PLLC is currently accepting NuVasive PRECICE System induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects or needed surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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