Zimmer Holdings is an Indiana-based orthopedics company involved in providing hip and knee solutions including joint and skeletal replacement systems and surgical tools as well as biologics designed to assist in joint replacement surgeries. In April 2014, Zimmer and Biomet announced to come together to provide a joint replacement, bone repair, and dental implant solutions. In June 2015, they started out as Zimmer Biomet and began offering solutions to the musculoskeletal healthcare industry. The hip and knee implant were intended to relieve pain, provide good quality of life to the patients. However, Zimmer lawsuits filed by several individuals claimed the metal-on-metal articulation used in the system resulted in Metallosis, because of the metal grounding on metal as it leads to toxic metal shards being released into the patient's surrounding tissues and bone.

The Food and Drug Administration (FDA) approved Zimmer Durom Acetabular Component (commonly known as Durom Cup) in 2006 for the use of total hip replacement to address the durability and range of motion of the joint. Most of Zimmer Holdings Inc. came to the market after going through the FDA's 510(k) clearance process. The young patients with more physical lifestyle were targeted and implanted, and it was observed it lead to serious injuries within a short time. The FDA received Zimmer Biomet's clearance notification on October 25, 2018, and granted the clearance on January 24, 2019, for ROSA Knee System. Zimmer Persona knee implant was approved by the FDA in December 2012.

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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.

Zimmer Biomet's Alleged Implants

• VerSys
• Taperloc
• Longevity
• Mayo Hip
• Durom Cup
• Mallory-Head
• M2a Magnum
• NexGen Flex Knee
• Persona Trabecular Metal Tibial Plate
• M/L Taper Hip Prosthesis with Kinectiv Technology

Serious Alleged Injuries May Include:

• Premature Loosening
• Severe Pain
• Inflammation And Swelling
• Limited Mobility
• Infection
• Bone, Joint, Muscle Or Neurological Damage
• Shedding Of Metal Debris Into The Bloodstream
• Metallosis (The Build-Up Of Metal Ions In The Body)
• Component Corrosion
• Popping, Crunching Or Other Noises From The Hip Caused By Movement
• Fractures Of One Or More Components

FDA Safety Warnings:

• 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 Durom Cup were noted. In September and December 2010, many implants were recalled.

• In March 2015, there was a recall for Persona Trabecular Metal Tibial Plate by the FDA. Several patients had to hire knee replacement lawyers.

• 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, Ind. during an inspection done in 2016. The violation was documented in Form 483.

Legal Updates:

Defendants: Biomet Inc., Zimmer Biomet Holdings Inc.

Defense Law Firms:

Biomet Inc. - Patterson Belknap Webb % Tyler LLP, New York, NY, and Ladue Curran % Kuehn LLC, South Bend, Indiana.

• McCarter % English LLP

In Re: Biomet m2a Magnum Hip Implant Products Liability Litigation (MDL No. 2391).

Defendants Lead Counsel :

John D Winter PHV, PRO HAC VICE - Patterson Belknap Webb % Tyler LLP, New York, NY

Defendants Liaison Counsel:

Defendant: Erin Linder Hanig, John David LaDue, LaDue Curran % Kuehn LLC, South Bend, IN; Jenya M Moshkovich PHV, PRO HAC VICE, Patterson Belknap Webb % Tyler LLP, New York.

Allegations:

The majority of the Hip/Knee replacement systems involve metal-on-metal designs and lawsuits claim the devices shed microscopic amounts of chromium or other metals into the body leading to metallosis.

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.

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.

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, 2018, the cases are presided by United States District Judge Hon. Paul A. Crotty in the U.S. District Court for the Southern District of New York.

Important Verdicts and Settlements

• June 2010: Zimmer Durom Cup lawsuits were consolidated in multidistrict litigation (MDL) in the U.S. District Court of New Jersey. Zimmer established a settlement fund of $47.5 million at this time.

• December 2014: The first bellwether for Durom Cup Hip Replacement System ended in a defense verdict for plaintiff John P. after an Illinois jury ruled unanimously ruled that the company did not purposely market a defective product.

• July 2015: A Los Angeles jury awarded nearly $9.2 million to plaintiff Gary Kline for claims filed for negligent design defect and failure to warn regarding Zimmer Durom Cup hip implant.

• November 2015: Zimmer secured victory in the first bellwether trial over complications linked to NexGen Knee implants.

• October 2016: Judge Rebecca Pallmeyer granted summary judgment on October 21 for Zimmer and other defendants in the second bellwether trial for NexGen asserting that the plaintiffs failed to present adequate evidence.

• January 2017: Zimmer won its third bellwether trial involving NexGen Flex knee product as the Illinois jury rejected plaintiff Marilyn Adams's claim that Zimmer failed to forewarn about health risks of the implant in obese patients.

• April 2017: Plaintiff Michael Brian McDonald was awarded $2 million in a case involving a Zimmer Kinectiv hip implant system.

• May 2017: As of May 2017, only around 300 cases remain pending in the MDL. Zimmer settled almost all of its Durom Cup lawsuits in March 2016 for an estimated $314 million. Many of the cases were dismissed before they could make it to court.

• August 2018: Judge Edward Smith of the Pennsylvania Federal Court dismissed a plaintiff's claim regarding metal-on-metal prosthetic hip since the statute of limitations on those claims expired.

• February 2018: The plaintiffs and defendants reached an almost settlement in a lawsuit involving its NexGen knee implant for an undisclosed amount in the MDL No. 2272.

• February 2019: In a notice filed in February 2019, the plaintiffs involved in Zimmer NexGen knee implant litigation have agreed to participate in the settlement program, which will leave only a few cases unresolved.

• August 2019: A plaintiff 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.

Evidence:

• Indication Of Zimmer Knee/Hip Usage In Medical Records
• Detailed Operative Reports
• Implant Sticker And Relevant Details Like Product Code, Manufacturer, Lot Number
• Follow-Up Complications And Their Treatment After Zimmer Knee/Hip Implant Insertion

Medical Record Review and claim validation of Zimmer Hip/Knee Replacement case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.