Elbow Implant Complications Result in Recall by DePuy

DePuy Synthes, a subsidiary of Johnson & Johnson, voluntarily recalled the Synthes Radial Head Prosthesis System, an implant that replaces part of the joint that makes the elbow. It is possible for the radial stem to loosen at the stem-bone interface. DePuy asks doctors to return any parts that have not already been implanted in patients who had elbow surgery.(1) (2)
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Like other patients, you are not alone in your pain or your frustration if your elbow implant has failed. Unfortunately, it turns out that many people may be struggling with the very same thing: loosening due to a DePuy Synthes Radial Head implant.

You may be able to pursue compensation for the pain, suffering, disruption, aggravation, and expenses related to this faulty implant. And Weitz & Luxenberg is here to help.

DePuy Synthes Recalls Elbow Implant System

On December 29, 2016, DePuy Synthes voluntarily recalled its Radial Head Prosthesis System for radial head replacement. This resulted in a voluntary product removal from the market of this joint replacement for the radial head in the elbow. The U.S. Food & Drug Administration (FDA) has classified this recall as Class 2.(3)

For a free consultation and more information about your legal options, please contact us today.

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A Class 2 medical device recall is something to take seriously.(4) According to the FDA’s information regarding the recall, “There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.”(5)

If you underwent elbow replacement surgery and received a DePuy Synthes Radial Head Prosthesis System implant, you should be aware of this recall. According to the FDA, DePuy recalled more than 50,000 products distributed in the United States.(6)

When a manufacturer recalls one of its medical devices, the company is acknowledging a potential problem. Adverse event reports made to the FDA indicate that loosening with the DePuy Synthes Radial Head Prosthesis System had been reported to the FDA for several years before the recall was initiated.(7) (8) (9)

DePuy Elbow Attorneys

If you underwent surgery for elbow replacement and received a potentially defective DePuy Synthes elbow implant, you may be eligible to pursue compensation from the manufacturer. Weitz & Luxenberg is now accepting cases regarding the DePuy Synthes Radial Head Prosthesis System, intended for primary or revision replacement of the radial head, a part of the elbow joint.

We are pursuing DePuy elbow claims on behalf of people who have experienced any of these complications due to their DePuy Synthes elbow implant:

  • Revision, or corrective, surgery because of complications due to loosening in your DePuy Synthes elbow implant
  • Symptomatic implant loosening that has not yet been resolved through surgery
  • Osteolysis (bone loss)
  • Pain
  • Poor joint mechanics/impaired range of motion
  • Bone fracture around the implant due to loosening
  • Soft tissue damage or irritation

Our attorneys are experienced in joint replacement lawsuits. They handle large-scale, often national cases involving defective drugs and medical devices.

In fact, Weitz & Luxenberg has represented thousands of people over the past 30 years who have been harmed by defective medical devices and the irresponsible actions of others. We have won billions of dollars in verdicts and settlements on behalf of clients like you who were seriously, sometimes irreversibly, harmed, through no fault of their own.

In recent years, Ellen Relkin, our Practice Group Co-Chair, was instrumental in reaching settlements with DePuy for a hip implant lawsuit, resulting in a $2.5 billion+ settlement.

If you received a DePuy Synthes Radial Head Prosthesis during elbow joint surgery, you may not have noticed signs of implant loosening yet. With this kind of surgery, however, routine checkups and follow up may provide you with information regarding the effectiveness of your implant.

During a checkup, a physician may notice loosening you were not aware of. Sometimes physicians discover the loosening by examining X-rays.

For more information about your legal options regarding the potentially defective DePuy Synthes Radial Head Prosthesis, we invite you to contact us immediately. You can reach us by calling (855) 524-0488 or completing the form on this page. One of our Client Relations representatives will respond to you shortly.

finger and pen pointing at paperwork.

Weitz & Luxenberg Initiating DePuy Elbow Lawsuits

Models of the DePuy Synthes Radial Head Prosthesis System have been loosening sometimes within a couple years of being implanted. According to the FDA’s MAUDE database, physicians and others have noted loosening of a DePuy Synthes elbow implant following surgery.(10) (11) (12)

Attorneys at Weitz & Luxenberg are investigating claims against DePuy Synthes on behalf of clients who underwent revision, or corrective, surgeries due to device failure, loosening, and other serious medical complications related to their DePuy Synthes Radial Head Prosthesis System implant.

In addition, if you have experienced DePuy elbow implant complications and have been advised by your doctor to undergo a revision surgery because your DePuy Synthes elbow implant failed, you may be eligible to pursue compensation from the manufacturer.

According to Ms. Relkin, “If you have undergone an elbow implant revision surgery because your DePuy Synthes Radial Head Prosthesis System implant failed due to loosening, contact us as soon as possible, so we can seek legal redress on your behalf.”

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.

(855) 524-0488

Depending on your circumstances, you may be able to receive compensation for your pain and suffering, medical expenses, physical therapy, lost wages, and other related expenses. We encourage you to speak with one of our Weitz & Luxenberg attorneys specializing in defective medical devices.

We offer a free consultation. Please call Weitz & Luxenberg now at (855) 524-0488, or complete the form on this page. One of our representatives will be in touch with you shortly.

DePuy Elbow Warnings

On December 30, 2016, DePuy Synthes distributed an urgent medical device field safety notice regarding its Radial Head Prosthesis System. According to the notice, the company initiated a product removal of the DePuy Synthes Radial Head Prosthesis System.(13)

The company stated, “The entire DePuy Synthes Radial Head Prosthesis System is affected by this removal.” Though the entire Radial Head Prosthesis System is affected, “the radial stem…has the possibility of loosening post-operatively at the stem bone interface.”(14)

Because DePuy Synthes was not able to “fully characterize” the reasons for the loosening, and thus was not able to “issue further instructions to surgeons that might lead to a reduction in issue rate” the company “decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market.”(15)

DePuy Synthes advised health care practitioners to monitor and follow up with patients who had received the DePuy Synthes Radial Head Prosthesis.(16)

Patient and husband talking with doctor.

Possible DePuy Elbow Implant Complications

According to DePuy Synthes, the following may occur if the radial stem becomes loose post-operatively:(17)

  • Device loosening
  • Osteolysis
  • Poor joint mechanics
  • Pain
  • Bone fracture, post-operatively
  • Soft tissue damage and irritation

Weitz & Luxenberg Can Help

As a national law firm with more than 30 years of experience, Weitz & Luxenberg is a firm you can trust. We have a solid history of winning and have represented thousands of people over the years.

“Weitz & Luxenberg was established in the mid-1980s specifically to help people who had been harmed by the irresponsible, sometimes unconscionable, actions of large corporations,” Ms. Relkin emphasized.

Medical device manufacturers sometimes rush to get their products to market. The earlier the products are made available, the sooner medical device manufacturers reap their rewards, watching their profit margins grow.

In the process, people sometimes get hurt. The medical devices patients hope will alleviate their pain and frustration sometimes result in even more pain, frustration, and expense.

At Weitz & Luxenberg, our attorneys are here for you.

The challenges you are facing along with the costs of corrective medical care may seem insurmountable. You may feel the crunch financially, but you may also have to struggle with debilitating medical and physical complications you never anticipated.

You should not have to live with these consequences. The person or company responsible should be held accountable.

At Weitz & Luxenberg, that is what our attorneys fight for — your right to full and appropriate compensation when you have been harmed by someone else’s actions.

Please, do not hesitate to contact us. We offer a free consultation and would welcome the opportunity to help you evaluate your legal options.

You can reach us by phoning (855) 524-0488 or by completing the short form provided on this web page. Someone will contact you shortly.

  1. U.S. Food & Drug Administration. (2017, August 16). Class 2 Device Recall Synthes Radial Head Prosthesis System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
  2. DePuy Synthes. (2016, December 30). Urgent Notice: Medical Device Field Safety Notification — Product Removal 555531— Radial Head Prosthesis System. Retrieved from http://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/00202-17_Kundeninfo_en.pdf?__blob=publicationFile&v=1
  3. U.S. Food & Drug Administration. (2017, August 16). Class 2 Device Recall Synthes Radial Head Prosthesis System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
  4. U.S. Food & Drug Administration. (2009, June 24). Safety. Retrieved from https://www.fda.gov/safety/recalls/ucm165546.htm
  5. U.S. Food & Drug Administration. (2017, August 16). Class 2 Device Recall Synthes Radial Head Prosthesis System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
  6. U.S. Food & Drug Administration. (2017, August 16). Class 2 Device Recall Synthes Radial Head Prosthesis System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
  7. U.S. Food & Drug Administration. (2016, March 1). MAUDE Adverse Event Report: Synthes USA Prosthesis, Elbow, Hemi-Radial Polymer. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5504989&pc=KWI
  8. U.S. Food & Drug Administration. (2015, October 20). MAUDE Adverse Event Report: Synthes USA Prosthesis, Elbow, Hemi-Radial, Polymer. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5202272&pc=KWI
  9. U.S. Food & Drug Administration. (2015, September 21). MAUDE Adverse Event Report: Synthes USA Radial Head Prosthesis System. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5048957&pc=KWI
  10. Ibid.
  11. U.S. Food & Drug Administration. (2016, May 6). MAUDE Adverse Event Report: Synthes USA 20mm CoCr Radial Head Standard Height/12.0mm-Sterile Prosthesis, Elbow, Hemi-Radial, Polymer. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5682455&pc=KWI
  12. U.S. Food & Drug Administration. (2015, January 20). MAUDE Adverse Event Report: Synthes Monument 22mm CoCr Radial Head Standard Height/12.5mm-Sterile Prosthesis, Elbow, Hemi-Radial, Polymer. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4485691&pc=KWI
  13. DePuy Synthes. (2016, December 30). Urgent Notice: Medical Device Field Safety Notification—Product Removal 555531—Radial Head Prosthesis System. Retrieved from http://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/00202-17_Kundeninfo_en.pdf?__blob=publicationFile&v=1
  14. Ibid.
  15. Ibid.
  16. Ibid.
  17. Ibid.

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