Oct 23

DePuy Synthes Recall for Defective Radial Head Prosthesis

Posted on October 23, 2019 — by Tom Foley III

Foley Law Firm Brings Lawsuit Against DePuy Synthes For Injuries Patient Suffered Resulting from Recalled Defective Radial Head Prosthesis System

An illustration of an elbow implantThe Foley Law Firm of Scranton, Pennsylvania, in conjunction with Philadelphia counsel, have filed what is believed to be the first product liability lawsuit in Philadelphia County involving a Radial Head Prosthesis System against Johnson & Johnson subsidiary DePuy Synthes of West Chester, Pennsylvania, B.A. v. DePuy Synthes for injuries to a patient suffered after implantation of a DePuy Synthes device. On December 29, 2016, after distribution of 50,311 Radial Head Prosthesis Systems, J&J and DePuy Synthes announced the recall of the radial head prosthesis.  DePuy Synthes acknowledged that “There is a possibility that the radial stem may loosen post operatively in the stem bone.”

The radius bone goes from the elbow to your wrist. The radial head is the top of the radial bone, just below the elbow.  On December 13, 2013, DePuy Synthes announced the launch of the Radial Head Prosthesis System for primary and revision joint replacement of the radial head to attempt to restore joint function. The company claimed that the system offered several benefits over current technologies.  DePuy Synthes claimed

“This system is a comprehensive solution for the radial head replacement that permits the surgeon to choose whether a long or short stem is best for the proximal radius,” said Harry Hoyen, M.D., consultant to DePuy Synthes Trauma with the Department of Orthopedic Surgery, MetroHealth Medical Center, Cleveland, Ohio. “With the system, a novel surface etching permits on-growth and stability, the head element can be placed onto either stem and is designed to take into account the PRUJ and radiocapitellar articulation for each respective size. There also is a side-loading opening for intraoperative assembly.” The modularity of the system - 24 heads and 10 stems allowing for 240 possible implant combinations - enables surgeons to restore the appropriate height, which may aid in elbow stability. The side-loading capability facilitates in-situ insertion and assembly, which may allow for a smaller incision than a top-loading device, while the stem texture ensures a uniform press fit in the radial canal. The system also provides an integrated connection crew to facilitate assembly, along with simple instrumentation.

DePuy Synthes was actually aware that metallic implants can loosen, fracture, corrode, migrate, disassociate at the head from the stem, or stem/bone interface, cause pain, or stress shield bone even after a fracture has healed.  Possible adverse effects resulting from implanting the DePuy Synthes radial head prosthesis system may include:

1.         Non-union or delayed union which can lead to breakage of the implant.

2.         Metal sensitivity, or allergic reaction to a foreign body.

3.         Limb shortening due to compression of the fracture or bone resorption.

4.         Decrease in bone density.

5.         Pain, discomfort, or abnormal sensations due to the presence of the device.

6.         Nerve damage due to surgical trauma.

7.         Necrosis of bone.

8.         Vascular changes.

The Complaint alleges that DePuy Synthes failed to adequately design and test the radial head prosthesis device prior to marketing in the United States, and failed to warn physicians and consumers of the product’s safety issues.  DePuy Synthes represented that it was substantially equivalent to existing devices, several of which have now been recalled.

On December 29, 2016, DePuy Synthes announced that it was removing the Radial Head Prosthesis System from the United States market due to the potential for the radial head to loosen at the stem bone interface. DePuy acknowledged complications associated with radial stem loosening including osteolysis (bone loss), poor joint mechanics, pain, postoperative fracture and soft tissue damage.

A Class 2 Recall Notice of the Synthes Radial Head Prosthesis System was issued by the Federal Food and Drug Administration (FDA) on or about February 2, 2017 stating that the “Manufacturer’s Reason for Recall: The radial stem may loosen postoperatively at the stem bone interface.”

The FDA reported that: on December 29, 2016, DePuy issued a recall for over 50,000 elbow joint replacement devices known as the “DePuy Synthes Radial Head Prosthesis System.” The company reported that the device’s radial stem, which attaches the device to the lower arm, may loosen after surgery. If loosening occurs the device may not function properly and can lead to other health problems such as, loss of bone tissue, post-operative bone fractures, soft tissue damage, and pain. As a result, on February 2, 2017, the U.S. Food and Drug Administration (FDA) classified the recall as a Class 2 device recall. The FDA classifies a recall as a Class 2 when the product may cause a temporary or reversible health problem or where there is a chance that it will cause serious health problems or death.

Depuy Synthes and/or its affiliates had received dozens of reports of radial head product malfunction and failure. 

A Medical Device Alert was issued in the United Kingdom by the Medicine and Healthcare Products Regulatory Agency recalling the products of Synthes GmbH on June 17, 2017:

MDA/2017/016         Issued:  12 June 2017 at 14:30

DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem.

Manufactured by Synthes GMBH – Recall of Radial Head Prosthesis System.

Associated Radial Head Prosthesis system parts also need to be returned to DePuy Synthes but will be available for revision surgeries of the radial head component.

  • Do not implant these devices (see details below).
  • Locate and return all affected products to DePuy Synthes as detailed in their Field Safety Notice.
  • Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability.
  • Consider monitoring patients at 6 monthly intervals for up to 2 years post-implantation, with both clinical and radiographic assessments (i.e. X-rays*) to identify possible loosening of the radial stem.
  • Any asymptomatic patients identified with loosening of their implants should continue to be monitored at 6-monthly intervals for progressive osteolysis (including potential risk of fracture), or the development of symptoms needing revision surgery.
  • Report all adverse events involving this device to DePuy Synthes and to MHRA or the appropriate Devolved Administration.

*In all cases, the benefit of ionizing radiation screening should be weighed against the risks from radiation exposure on an individual basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000.

DePuy Synthes failed to timely advise the FDA, physicians, and/or consumers of the risk of loosening and disassociation of the radial head prosthetic system and the resultant delay in healing and/or need for reoperation.  DePuy Synthes’ warnings of these risks were incomplete, inadequate, and/or minimized the risk of injury.

Osteolysis means bone loss around the prosthetic device.  Osteolysis can lead to serious problems and may require additional surgery for treatment. 

Bone loss around the implant occurs leading to what is referred to as “aseptic loosening” which is loosening of the implant without any infection.  Loosening of a “press fit” prosthesis may lead to extensive osteolysis.

Symptoms and conditions associated with osteolysis include pain with implant movement and reduction in range of motion of the implant.  As the loss of bone around the implant proceeds, the body responds by creating scar tissue in an attempt to stabilize the joint.  The patient experiences a loss of range of motion of the joint containing the implant, such as a feeling the joint has become stiff and will not extend to the degree it could previously.

Osteolysis can induce inflammation in and around the implant, both due to the loss of bone and due to particles and molecules that shed from the implant. Inflammation can result in swelling, redness, discomfort and even fever like feelings.

Bone loss due to osteolysis can be treated in several ways, including bone grafts or synthetic substitutes.

Abnormal bone growth or bone spurs can grow where there is loss of bone around the implant, which can cause pain and interfere with movements of the joint, or become visible as an obvious abnormality in the joint.

If you have had a DePuy Synthes radial head prosthesis system implanted in your elbow, osteolysis can take years to develop and may require additional surgeries.  Loosening of the prosthesis can occur either early following surgery or late. Call the Foley Law Firm to evaluate your case in order to preserve evidence and your claim.

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