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Zimmer Hip Replacement LawsuitZimmer Holdings Inc., maker of hip-replacement devices,recalled its Durom Cup hip

replacement implant. They then set aside $271.7 million for lawsuits filed by patients who

neededadditional surgeryafter having the companys Durom Cup implanted.

Originally, Zimmer only accepted legal claims for surgeries performed before July 22, 2008,and those with a revision surgery performed within two years after the original implant.

Zimmer estimated that as of September 30, 2011, the remaining liability for surgeries

performed before July 22, 2008 was $142.6 million.

Zimmer later was forced to revise its stance to include all claims for surgeries performed

globally before July 22, 2008, regardless of the amount of time between the revision surgery

and the original implant.

In its November 2011 statement of earnings, Zimmer said it planned to record any provisions

for Durom Cup claims in which theoriginal surgerywas performed after the 2008 deadline as

part of its product liability accruals. By September 2011, Zimmer had provisions totaling $10.2

million for those post-deadline claims.

Zimmer also stated in its earnings filing that it expected to pay the majority of the DuromCup-

related claims within the next three years. However, the Company also added that the number

of legal claims and the amount it pays to settle these claims may be more than anticipated.

Zimmer Durom Cup Lawsuits

The Durom Acetabular Component orDurom Cup, as it is commonly known is constructed

of a single sheet of cobalt chromium alloy metal. It was developed to be used in total hip

replacement surgery in conjunction with larger diameter replacement heads for the thigh

bone.

The device has a pure titanium plasma-sprayed coating that fixes it in place. In compliance

with Food and Drug Administration (FDA) regulations, the Durom Cup sold in the United States

was slightly different than those sold abroad in that its structure had a slightly thicker coating.

Zimmer voluntarily suspended sales of the Durom Cup in July 2008, but it was reintroduced tothe market a few months later.

FDA Warnings and Study Results

The FDA advises patients to be aware that metal-on-metal devices are not suited for everyone

There are some specific factors that determine if a patient is a good candidate or not.

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If a patient meets any of the following criteria, they should not be given a metal-on-metal

implant:

Kidney problems Allergy or sensitivity to metals Suppressed immune system Receiving high doses of corticosteroids Child-bearing ageIn addition, the FDA notes that people with smaller body frames may be at greater risk for

adverse reactions and device failure if they receive a metal-on-metal implant.

Analysis Disproves Metal-on-Metal Superiority

A study published in BMJ (British Medical Journal) reported an analysis of 18 studies that

reviewed implanted hip devices that featured various surfaces. The studies comprised 3,139patients and more than 830,000 operations.

The analysis documented a discovery of what physicians call functional outcomesa persons

ability to perform daily, routine activities and ability quality-of-life events were the same

between patients with the metal-on-metal hip implants and traditional hip implants. This

signifies that manufacturer claims of the superiority of the newer, supposedly superior metal-

on-metal devices are not true.

The three largest national registries for devices in Australia, New Zealand and England/Wales provided data that showed there were higher rates of revision surgery associated with

metal-on-metal implants compared with traditional metal-on-polyethylene implants.

Polyethylene or polythene is the most common plastic.

In addition, 17 of the 18 studies reported a higher incidence ofhip dislocationin patients who

received metal-on-metal implants.

Another published in the Journal of Bone and Joint Surgery found that the concentrations of

chromium and cobalt ions in the blood of 64 patients after one year of having received the

Durom metal-on-metal surface replacement was 1.61 micrograms per liter of whole blood forchromium and 0.67 of a microgram per liter of whole blood for cobalt.

The researchers concluded that the levels of metal ions released into the blood may be

specific to the Durom hip resurfacing implant and are a product of its manufacturing process.

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