Hip Revision Surgery

Unfortunately, the increase in hip replacement surgeries has meant an increase in issues with implants.

There are five types of hip implants that are broken down into the components used:

Metal-On-Metal (MoM)
Metal-On-Polyethylene (MoP)
Ceramic-On-Metal (CoM)
Ceramic-On-Polyethylene (CoP)
Ceramic-On-Ceramic (CoC)

Each type has its advantages and disadvantages. For example, the most common type of hip implant — Metal-on-Polyethylene — has excellent wear resistance and a lower risk of side effects. Long-term durability is an issue due to plastic debris from wear.

But the type of implant with the most number of adverse events is Metal-on-Metal, which has required a growing number of patients to undergo hip revision surgery.

Metal-on-Metal implants were first introduced as a more durable and effective hip implant. This appealed to younger patients because it meant they could potentially go through the remainder of their life without needing revision surgery or replacement.

Unfortunately, that hasn’t always been the case.

Not long after the rise in MoM implants, more people were reporting failures and incidence of metal poisoning. Metallosis occurs when the metal components of the implant rub against each other and release tiny metal particles into the surrounding tissue. Metal poisoning can lead to serious complications, including heart failure and infection.

Studies have also backed up the number of complaints. Two large studies looking at people with hip found those with metal implants were more likely to experience failures and require revision surgery.⁵

The dangers of MoM implants have become so apparent that the U.S. Food and Drug Administration has issued multiple warnings to patients thinking about getting the implants.

Thousands of lawsuits related to MoM implants have been settled since 2000.

One of the largest settlements came in November 2013 when DePuy announced it had agreed to a settlement that could reach up to $4 billion.⁷ The agreement settled thousands of cases against Johnson & Johnson’s DePuy over its Articular Surface Replacement (ASR) metal-on-metal hip.

In 2014, Stryker also agreed to a large settlement that was expected to cost about $1 billion.⁸ The lawsuits were related to two hip implants — Rejuvenate Modular-Neck and ABG II Modular-Neck — that were recalled in 2012 after complaints of failure.

Other manufacturers have also agreed to settlements over their metal implants.

Stryker Rejuvenate Modular and ABG II Neck Cases
In August 2012, Stryker recalled two of its modular-neck hip implants, the Rejuvenate and ABG II. These products feature a metal-on-metal component in the neck/stem joint, which is prone to corrosion, fretting, and shedding toxic splints of metal into the patient’s body over time, leading to a condition known as metallosis. A common side effect of metallosis is the development of pseudotumors in tissue surrounding the implant site.

Over 3,000 lawsuits were centralized in a federal Multi-District Litigation (MDL No. 2441) under U.S. District Judge Frank. The company agreed to pay $1.4 billion to settle about 1,500 of the lawsuits in 2014.

Stryker Accolade, Citation, Meridian, Exeter, Reliance,Definition and Restoration Stem cases with V40 Cobalt Chromium modular heads.
In 2015, Stryker notified surgeons of a voluntary recall of certain hip devices that feature cobalt and chromium heads due to serious design flaws that could lead to health risks and compromised patient safety. These stems have the potential for significant corrosion where the cobalt and chromium heads of the patient’s hip implant disintegrate such that the head ultimately breaks from femoral stem, referred to by surgeons as “spontaneous dissociation”. This type of catastrophic failure requires an invasive emergency surgery to remove both pieces of the hip implant.

Patients who have experienced metallosis, head dissociation or Trunnion/Taper deformation as a result of receiving the above Stryker hip implants should call

Wright Medical Conserve Cup (MOM) cases
A growing number of metal-on-metal (MoM) hip replacement patients are reporting serious problems with their Wright Conserve hip replacement systems. The Wright Conserve is a modular implant, which consists of a femoral stem, modular neck, and femoral head with an artificial acetabular cup.

The following Wright hip components have been the subject of lawsuits:

Conserve Total Hip System
Conserve Total A-Class Advanced Metal
Conserve Plus Total Resurfacing Hip System
Conserve Femoral Surface Replacement

MoM hip replacements such as the Conserve have been linked to serious conditions such as infection, broken bones, and metallosis, which can lead to nerve and cognitive impairment and death.

Wright Medical Profemur Stem Cases
The FDA issued a Class 1 recall of certain Wright Medical Profemur modular neck stems due to an unexpectedly high number of patients reporting a snapping, or fracture, of their Profemur hip system at the stem.

The Wright Medical Profemur stem differs from other hip implant systems in that it includes an additional component, which is a modular neck. This neck connects the head or ball with the stem that is implanted into the patient’s femur.

There are 4 types of Wright Medical Profemur stems that utilize these modular necks that have experienced fractures:

PROFEMUR Gladiator
PROFEMUR Renaissance
PROFEMUR TL
PROFEMUR Z

Patients who received Wright Medical Profemur Stem implants are susceptible to implant fracture (either the titanium or CoCr necks) and metallosis.

DePuy ASR
The DePuy ASR (Articular Surface Replacement) was marketed as a preferred hip replacement that allowed for greater range of motion and would last longer than previous hip replacement products on the market. In 2010, DePuy acknowledged that its ASR device had a 12% revision rate within five years of implantation, and internal documentation later released by the company showed DePuy’s knowledge of a 37% revision rate within less than five years of implantation. DePuy consequently issued a voluntary recall of the ASR hip implant device on August 24, 2010.

On November 19, 2013, a $2.5 billion settlement program meant to compensate injured patients was announced in the DePuy ASR Metal-on-Metal Hip Implant Litigation. The DePuy ASR settlement program was meant to compensate approximately 8,000 patients who experienced metallosis and other forms of toxicity attributable to metal disintegration and wear from the ASR device and who underwent hip revision surgery to replace the defective implant. The settlement program has subsequently expanded to include additional claimants who underwent subsequent revision surgeries and may exceed $4 billion in amount after all claimants have been properly compensated.

Depuy Pinnacle Metal on Metal (MOM) with modular heads greaterthan 36 mm.
Johnson & Johnson and DePuy Orthopaedics are facing thousands of lawsuits due to their defective metal-on-metal hip implants. The Pinnacle hip implants, which are produced by Johnson & Johnson’s subsidiary DePuy Orthopaedics, are linked to multiple adverse health outcomes including metallosis, tissue death, and bone erosion.

As of March 15, 2017, over 8,875 lawsuits are consolidated for pretrial proceedings in MDL 2244. Among claims made in each Pinnacle lawsuit is that DePuy Orthopaedics failed to warn patients and the medical community about the risks associated with the DePuy Pinnacle hip replacement device.

Revision surgeries may sometimes be necessary to repair or mitigate the damage caused by these devices.

Zimmer M/L Taper Kinectiv Stem cases (this is their Modular neckdesign)- All cases with Metallosis.
The FDA issued a recall for the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks hip implants on June 19, 2015. Patients are at an increased risk for allergic reactions such as metallosis, pain, infections, or death related to high level of manufacturing residue on these implant components. The FDA has opined that revision surgery to replace the defective implants may be necessary for some patients.

The Kinectiv devices were designed to match a wide range of male and female anatomies without compromise through a broad spectrum of modular neck components.

Zimmer Durom Cup cases with modular heads greater than 36 mm.
The Zimmer Durom Acetabular Component is a type of artificial hip that was introduced in the United States in 2006. It is designed for use with Zimmer’s Metasul Metal-on-Metal Tribological Solution Large Diameter Heads (LDH). Unlike traditional hip replacement components, the Zimmer Durom Cup is made from a single piece of material.

After initially dismissing reports of problems with their device, Zimmer agreed to initiate an investigation of the Durom Cup problems in May 2008. After reviewing data from over 3,100 cases, Zimmer concluded that the technology and design specifications of the Durom Cup require a higher degree of precision than is typically found in hip replacement surgical techniques in the United States and that additional instructions and training should be provided to doctors before the devices are implanted

Possible complications associated with implantation of the Durom cup device include the need for additional revision surgeries, unexplained hip pain more than three months after hip replacement, loosening of the hip implant, metallosis, and infection.

Zimmer Versys CoCr Head cases – All cases with Metallosis.
The Zimmer VerSys stem can be matched with many different Zimmer heads. Friction caused by normal movement of the metal cup and femoral stem can cause cobalt and chromium particles to shed, resulting in metallosis or metal poisoning. This problem is sometimes referred to as mechanical assisted crevice corrosion.

(Put w/ the Durom Cup cases as the V heads are often implanted with other Zimmer products).

Biomet M2A 38mm / Magnum cases. ALL cases with Metallosis.
The M2-Magnum metal-on-metal device is manufactured by Zimmer Biomet and is used in total hip replacement procedures. The M2A-Magnum device included a cup, liner, and ball, all comprised of metal. Biomet’s M2A line of hip devices included a larger head diameter than other products on the market, ostensibly to increase range of motion for active patients. The larger diameter meant a larger surface area rubbing against the cup component piece, which can lead to increased erosion of the metal particles and release of toxic ions in the body. This exposure to toxicity can lead to metallosis and other infections.

The Biomet M2A-Magnum is prone to early failure and can lead to the following complications:

Loosening Of The Device
Severe And Prolonged Hip Pain
Necessary Revision Surgery
Swelling
Difficulty Ambulating
Metallosis

DJO / Encore MOM hip cases. All cases with Metallosis.
Encore Medical, a Texas-based medical device manufacturer, is now owned by DJO Surgical ofSan Diego, California.

The Encore hip device features a unique design. Unlike traditional metal-on-metal hips available on the market, the Encore is designed with a metal insert on a polyethylene (plastic) liner, often referred to as a “poly sandwich” design. The liner is made of chromium and cobalt metal as are many metal-on-metal devices.

When the metal ball and socket grind against each other, pieces of chromium and cobalt can accumulate around the joint. Eventually these particles erode tissue surrounding the implant, resulting in inflammation such as metallosis, infection, and pseudotumors.

Omnilife Apex Arc – This is a smaller manufacturer but thisdevice is a mixed metal modular neck device. ALL
Patients who receive the Apex Arc Hip implant should know that the metal-on-metal hip replacement system is made similarly to other recalled implants. When OmniLife Science testified before the FDA in 2010, they piggybacked on the success of the Stryker and Johnson & Johnson implants that were previously approved by the administration. Apex company representatives harped on the ways in which the Apex Arc Hip device was similar to their competitors’ implants in order to receive FDA approval.

Cases involving metallosis and failure of the modular chromium and cobalt neck of the Apex ARC hip implants are being reviewed. We are aware of one pending case filed in state court in Massachusetts against this manufacturer. The plaintiff alleges design flaws in the hip implant such that the implant caused plaintiff to suffer from severe pain, swelling, pseudotumors and high levels of cobalt and chromium in her blood.

Smith & Nephew BHR R3 (MOM) cup cases. Only cases that havemetallosis and were revised or need a revision.
Smith & Nephew issued a recall of its BHR (Birmingham Hip Resurfacing) hips in 2015, after receiving numerous complaints about problems associated with this device.

The BHR device consists of a femoral head and a hemispherical acetabular cup made in a range of 12 sizes. The cup fits into the hip socket, or acetabulum, and then rubs against the femoral head whenever the patient walks or moves their hip. Both components are made of cobalt and chromium metal pieces. The myriad problems associated with the BHR and the R3 liner are similar to the injuries caused by other metal-on-metal hip devices, which have been well documented starting with the August 2010 recall of the DePuy ASR device.

As many as 25 percent of patients who received BHR hips will experience premature failure due to metallosis, toxicity due to excess levels of cobalt and chromium, and other symptoms related to the design of the device, and will require revision surgery.

Smith & Nephew SMF stem (this is their mixed metal modular neckproduct). All cases with Metallosis.
Smith & Nephew recalled their modular SMF and Redapt Femoral Hip Systems in November 2016 after receiving reports of adverse effects and complications similar to those reported with regard to other implants on the market.

A common complaint is that metal toxins are released into the patient’s body due to the metal components eroding and splintering off during normal use. This causes tissue, muscle and bone surrounding the implant site to break down and become infected. Another concern is metal poisoning from the release of toxins into the body, which can cause permanent organ damage.

On November 15, 2016 Smith & Nephew issued a voluntarily recall of the modular neck of the Modular SMF and Modular REDAPT Revision Femoral Hip Systems, which was posted within the FDA as an Urgent Field Safety Notice and Corrective Action Recall.. Smith & Nephew noted that the number of adverse events reported was higher than other similar hip implant systems, necessitating the recall. Specifically cited in the letter was the risk of tissue damage due to metal debris from the implants, which can lead to the need for revision surgery to remove the defective implants.