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DePuy, Food & Drug Administration, hip, Hip Replacement, Johnson & Johnson, metal, Patient, WAOW, Wisconsin
Dozens suing over hip replacement device
Posted: Jun 15, 2011 9:29 AM; By Courtney Fasano, Multimedia Journalist - bio | Source – click here
Swartz and his wife hoped to retire after he got a hip replacement, but he says after his first surgery life has been far from relaxing.
“It hurt all the time. It’d hurt every time I’d take a step it’d be aching,” Swartz said.
He says he got the hip replacement back in 2009 but his pain never went away.
“Lot of people had new hips put in, it was great, they can do everything they used to do. To me, I couldn’t,” Swartz said.
It’s this product made by a Johnson & Johnson company called DePuy Orthopaedics that was used to replace his hip.
DePuy recalled that replacement system last year for a variety of issues including manufacturing problems, infections and increased pain.
Attorneys at Habush Habush and Rottier say the way the device is designed, could put patients at risk because the parts grind against each other. In some cases, they say metal fragments are getting into patient’s bloodstreams.
“One of the adverse impacts of this recall products is that the ball grinds against the cup and can cause this metallic flaking, metallic ions to be released into the hip joint, into the tissue surrounding it,” said Attorney Peter Young.
DePuy Orthopaedics said it’s following FDA guidelines for metal-on-metal hips, and released this statement:
“DePuy’s top priority is and always has been patient safety. We understand that this recall is concerning for patients, their family members, and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need,”
Richard Swartz, has since had a second hip replacement and said he’s doing better, but wants to make sure no other patients go through a surgery like he did, that results in more pain.
“A person shouldn’t have to suffer like this because of a manufacturers mistakes.”
Attorneys say this case is still in the early stages.
DePuy Orthopaedics, Inc. Statement:
DePuy’s top priority is and always has been patient safety. We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.
The company has made detailed recall information available onwww.depuy.com and has created a help line for patients to have their questions answered and submit claims for reimbursement. We encourage patients to call the ASR Help Line at 1-888-627-2677.
In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System. This data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was not in line with data previously reported to DePuy.
DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. ASR patients should contact the ASR Help Line at 1-888-627-2677 for assistance.
The Food and Drug Administration recently provided guidance on metal-on-metal hips. Regarding metal ion levels, the FDA stated, “Different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be.” The FDA also noted, “Based on the limited number of case reports in published literature, the true incidence or prevalence of adverse systemic effects from MoM hip implants is not known at this time, but is believed to be rare.”
Online Reporter: Courtney Fasano
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when will the catastrophes like these will end?
Soon I hope – but greedy companies that don’t do their homework or, as in this case, chase market share and ignore the experts, will keep causing problems. Overall you would expect most DePuy ASR’s to be replaced earlier than required normally but with Broadspire in there, they will be pushing back hard the longer it goes. It will be a shit fight to the end I imagine. Revision rates are around 30% or more in the UK already.
Earl
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