Charlotte Personal Injury Lawyer - Medical Devices & Implants

Hip Replacement Gone Bad - Zimmer Durom Cup

Greg Jones — Tue, 22 Sep 2009 12:24:05 GMT

Hip Replacement Surgery, usually a procedure reserved for the elderly, is now becoming more and more common among young people, especially young athletes. It is a risky and difficult surgical procedure for any patient, and as such, doctors often prefer to try other methods of rehabilitation for their patients, such as:

physical therapy

walking aids

anti-inflammatory drugs

cortisone injections

joint supplements

hip resurfacing

hip fusion

resection anthroplasty (the bone around the hip joint is removed and allowed to fill with scar tissue)

hip osteotomy (when the bones of the hip joint are realigned)

Even if all other the other therapies are unsuccessful, doctors still prefer to limit hip replacement surgeries to the patients that are suffering from the worst symptoms, or to the patients whose quality of life has been drastically reduced by their pain. If hip replacement surgery is absolutely necessary, then the patient will have to undergo a procedure in which parts of the hip will be removed, and replaced with artificial implants.

After this surgery, patients are often at risk for a variety of negative side effects, such as blood clots, infections, or joint stiffening. However, there was another, much nastier side effect that surfaced between 2006 and 2008: the malfunctioning of the Durom Cup (one of the artificial components of hip surgery) made by the Zimmer Company.

The Zimmer Durom Cup had been approved for use in Europe since 2003, three years before the FDA approved its use in the United States. However, doctors in America noticed that the surgeries they performed with the Zimmer Durom Cup often resulted in a painful failure for the patients. The cups would either loosen in the sockets, coming loose at the slightest touch, or they would actually migrate to a different part of the patient's leg, no longer serving their purpose. These malfunctions were very painful for the patients, and often resulted in expensive reparative medical procedures.

After a public outcry over the ridiculously high rate of failure by the Zimmer Durom Cup, Zimmer pulled their product from the market in 2008 (despite their insistence that the fault lay with the doctors, and not their product), and has set aside over $47 million to pay for the impending lawsuits. It did not stay off the market for very long, however, and is being used again in the United States, albeit this time by many fewer surgeons. Nevertheless, if you find yourself needing medical treatment for your hip, you may want to strongly consider a less invasive, more therapeutic option, such as those listed above.

Originally posted at InjuryBoard by Greg Jones

Medtronic Recall over Infusion Pump and Catheter

Greg Jones — Wed, 16 Sep 2009 09:55:05 GMT

Medtronic Inc. has issued a statement that a catheter and an infusion pump it produces pose serious health risks when used together. This action and potential risk has caused the U.S. Food and Drug Administration to classify the combination as a Class 1 recall.

The two products – the Sutureless Connector intrathecal catheter and the IsoMed constant-flow infusion pump – are still able to be produced because they only pose risks when used together, according to Medtronic spokeswoman Cindy Resman on Monday.

The product recall is about the SC Catheter and Revision Kit Models 8709SC, 8731SC, 8578, and 8596SC, when paired with the IsoMed Pump Model 8472. The particular IsoMed Pump was discontinued in September 2008 “as part of a planned product phase-out,” according to the company.

A disruption in therapy and revision surgery, putting a patient at risk for serious injury or death, are the potential damages, Medtronic said.

Physical signs can include “a drug or cerebrospinal fluid leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe (“spinal”) headache, and/or a clinically significant or fatal drug underdose,” Medtronic said.

The company voluntarily sent notification letters to doctors in a process that began in August and is ongoing, it said.

Medtronic said patients should seek medical attention immediately if they experience underlying symptoms or drug withdrawal symptoms.

Originally posted at InjuryBoard by Greg Jones

Recall of certain Medtronic Kappa and Sigma Series pacemakers

Greg Jones — Thu, 11 Jun 2009 13:53:23 GMT

The FDA just announced Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Medtronic Kappa Series 600/700 and 900 as well as Sigma Series Series 100,200 and 300 pacemakers were involved in the recall.

Originally posted at InjuryBoard by Greg Jones