Zimmer Biomet, a medical device company, is facing several lawsuits over its Hip & Knee Replacement devices, claiming that microscopic amounts of chromium or other metals are shed into the body, leading to metallosis. We have collated all the relevant facts, FDA regulations, MDL proceedings, and important verdicts and settlements to provide lawyers and consumers a broader view of the growing litigation. Discover more about it through Zimmer Hip & Knee Replacement: Embroiled In Metallosis Lawsuits. To learn about our Medical-Legal Outsourcing services, visit https://www.neuralit.com/

1. Zimmer Hip & Knee Replacement:
Embroiled In Metallosis Lawsuits
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2. Zimmer Hip & Knee Replacement
In 2015, Zimmer Holdings, an Indiana-based orthopedics company, and Biomet, Inc.,
a medical device manufacturer, merged and commenced as Zimmer Biomet, offering
joint replacement, bone repair, and dental implant solutions.

3. The surgery involves replacing the worn-out bone and cartilage lining the hip or knee
joint with new implants that are made of materials such as ceramic, metal, and
plastic.
Hip & Knee Replacement Surgery
Hip and knee replacement surgery is often performed due to aging, injuries, and one
of the most increasing factors, obesity.

4. How Does It Work?
During the surgery, the damaged cartilage surfaces at the ends of the femur and
tibia are removed along with a small amount of underlying bone. The implants
are then placed in the cavity, which recreates the surface of the joint.
The procedure helps relieve pain caused by joint trauma or degenerative disease
like osteoarthritis and restores mobility, making walking easier.

5. Total Hip & Knee Replacement Statistics
Hip and Knee Arthroplasties
performed in the U.S.
Source: iData Research

6. Manufacturer
Zimmer Biomet
Holdings, Inc.

7. Zimmer Hip & Knee Replacement
Sales Statistics
Region-wise net sales of Zimmer Biomet
from 2014 to 2019.
Source: statista.com
These statistics illustrate how largely Zimmer
Hip & Knee Replacement is used worldwide.

8. Zimmer Biomet's Alleged Implants
Zimmer
Biomet
TaperlocVerSys
Persona
Trabecular
Metal Tibial Plate
NexGen Flex KneeMallory-Head
Durom Cup
Longevity
M/L Taper Hip
Prosthesis with
Kinectiv Technology
Mayo Hip
M2a Magnum

9. Serious Alleged Injuries Include
Metallosis
Infection
Severe pain
Limited mobility
Premature loosening
Component corrosion
Inflammation and swelling
Fractures of one or more
components
Bone, joint, muscle, or
neurological damage
Shedding of metal debris into
the bloodstream
Popping, crunching, or other
noises from the hip caused
by movement

10. Total Hip & Knee Replacement
Injuries Statistics
Statistics-revision of the total hip (THA)
& knee (TKA) arthroplasty injuries.
Source: ResearchGate

11. In March 2015, Persona Trabecular Metal Tibial Plate was recalled by the FDA.
FDA Regulations
Zimmer Holdings Inc. was targeted by the FDA as several reports of adverse events
and complications related to the NexGen Flex Knee as well as the Durom Cup were
noted. In September and December 2010, many implants were recalled.

12. On October 31, 2018, Zimmer Biomet announced that it received FDA 510(k) clearance
for the Persona Revision Knee System used in the revision knee replacement
procedures.
FDA Regulations
In August 2018, Zimmer Biomet revealed it received a warning letter from the FDA
over quality violations at a plant in its home base of Warsaw, IN, during an
inspection done in 2016. The violation was documented in Form 483.

13. Allegations: Lawsuits claim that the devices, involving metal-on-metal design,
shed microscopic amounts of chromium or other metals into the body leading to
Metallosis.
Lawsuit Status
Defendant: Zimmer Biomet Holdings, Inc.

14. Lawsuit Status
MDL Status: Zimmer Biomet faces thousands of lawsuits, which has led to recalls,
the formation of four MDLs, and settlements in millions.
MDL No.: 2158 (In Re: Zimmer Durom Hip Cup Products Liability Litigation)
Formed in 2010, the cases are presided by United States District Judge Susan D.
Wigenton in the U.S District of New Jersey.
MDL No.: 2272 (In Re: Zimmer NexGen Knee Implant Products Liability Litigation)
Formed in 2011, the cases are presided by United States District
Judge Rebecca R. Pallmeyer in the U.S. District Court for the
Northern District of Illinois.

15. Lawsuit Status
MDL No.: 2391 (In Re: Biomet M2A Magnum Hip Implant Products Liability Litigation)
MDL No.: 2859 (In Re: Zimmer M/L Taper Hip Prosthesis or M/L Taper Hip Prosthesis
with Kinectiv Technology and VerSys Femoral Head Products Liability Litigation)
Formed on October 3, 2012, the cases are presided by United States District Judge
Robert L. Miller, Jr. in the U.S District Court for the Northern District of Indiana.
Formed on October 3, 2012, the cases are presided by United States District Judge
Robert L. Miller, Jr. in the U.S District Court for the Northern District of Indiana.

16. Lawsuit Status
MDL No.: 2391
(In Re: Biomet M2A Magnum Hip Implant Products Liability Litigation)
Formed on October 3, 2012.
The cases are presided by United States District Judge Robert L. Miller, Jr. in the
U.S District Court for the Northern District of Indiana.

17. Important Verdicts & Settlements
February 4, 2019: Judge Arthur D. Spatt of the U.S. District Court for the Eastern
District of New York granted summary judgment to Zimmer Inc., after finding that
plaintiff Elizabeth Webb's injuries were not caused because of inadequate warnings
regarding the knee replacement system.

18. Important Verdicts & Settlements
February 2019: The plaintiffs involved in Zimmer NexGen
knee implant litigation agreed to participate in a settlement
program, which was announced by the manufacturer a year
back then to resolve cases filed in state and federal courts.
August 2019: Plaintiff Gary Kline was awarded $7.68
million by a California state jury for the pain and suffering
caused due to Zimmer’s defective implant that forced him
to undergo two hip replacement operations in 15 months.

19. Thank You
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