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DePuy, Food & Drug Administration, Health Canada, Hip Replacement, Philadelphia, Stryker, Stryker Rejuvenate, THE LANCET
Levin, Fishbein, Sedran & Berman Alerts Hip Patients to Stryker Rejuvenate Recall – Health News – redOrbit.
Levin, Fishbein, Sedran & Berman Alerts Hip Patients to Stryker Rejuvenate Recall
Philadelphia, Pennsylvania (PRWEB) July 13, 2012
Levin, Fishbein, Sedran & Berman, a prominent national plaintiff law firm, alerts patients implanted with a Stryker Rejuvenate Modular and ABG II modular-neck hip stems to the recent announcement of a voluntary recall of these devices. According to the Stryker website, the company initiated the Stryker Rejuvenate recall due to the increased risk of metal corrosion and the associated tissue damage. Patients who may be experiencing pain, swelling, immobility, premature loosening, or other complications potentially requiring revision surgery, may be eligible for compensation.
Metal-on-metal hip devices, such as the recalled DePuy ASR and Zimmer Durom Cup, have come under attack in recent years because of the tendency for metal components to rub against one another, depositing shards of chromium and cobalt into the patient’s tissues and bloodstream. According to a recent study published in THE LANCET, failure rates for these devices is six percent, compared to only 1.7–2.3 percent observed in other types of implants. Researchers concluded: “Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.” The BRITISH MEDICAL JOURNAL also published an article in February 2012 noting that some of these devices release metal ions on a much greater scale than previously thought, and that these ions can “seep into local tissue causing reactions that destroy muscle and bone and leave some patients with long term disability.”
The Stryker modular stem hip implants were not considered true metal-on-metal implants initially, because they contain a ceramic component and do not place a metal ball against a metal socket. They do, however, place a metal femoral stem against a separate metal neck. Unlike other hip systems that have a fixed length, one-piece femoral stem, the Stryker has several mix-and-match stem and neck components to give the surgeon more options. The problem occurs when the metal neck and stem come under stress, such as that experienced in an actual patient. This stress creates wear on the metal-on-metal junction, increasing the risk of metallic debris.
In April 2012, Stryker Orthopedics issued an “Urgent Field Safety Notice” indicating that patients could potentially develop metallosis from the Rejuvenate Modular Hip Implant System, which could lead to complications like bone damage, immunological problems, significant pain, allergic reactions, tissue damage and death, and elevated blood levels of cobalt. In May 2012, Health Canada announced a Stryker Rejuvenate recall so the instructions for use could be updated. To date, the FDA has received over 60 adverse event reports related to these devices, with patients describing metal toxicity requiring revision surgery. These reports are believed to have contributed to Stryker’s decision to recall these devices. This most recent recall follows on the heels of another Stryker recall announced in April 2012, in which the company pulled the MITCH TRH modular head / acetabular cup from the New Zealand market due to higher revision rates than that of all other total hip implants.
Levin, Fishbein, Sedran & Berman has a long and successful history as a leading Plaintiff firm protecting the rights of patients affected by defective drugs and medical devices. The firm has lead in highprofile cases in federal and state courts across the country. Though unable to guarantee results, the firm has a 20+ year distinguished track record of success and is highly committed to each case and to each victim it represents.
If you or a loved one has suffered an injury allegedly caused by the Stryker Rejuvenate or ABG II modular-neck stems, contact Levin, Fishbein, Sedran & Berman for a free and confidential case review at 1-877-882-1001, or visit their website at lfsblaw.com. You may be entitled to recover damages and ease the financial challenges of medical treatment.
CONTACT:
Michael M. Weinkowitz, Esquire
MWeinkowitz(at)lfsblaw(dot)com
or
Laurence Berman, Esquire
LBerman(at)lfsblaw(dot)com
Levin, Fishbein, Sedran & Berman
510 Walnut Street
Suite 500
Philadelphia, PA 19106
Toll Free Telephone: (877) 882-1001
Fax: 215 592-4663
Attorney Advertising. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/7/prweb9694113.htm
Source: redOrbit (http://s.tt/1hUfQ)
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