DePuy Elbow Implant Recall Lawsuit | 2026 Latest Updates

DePuy Synthes recalled its Radial Head Prosthesis System, an elbow implant made by Synthes (USA) Products LLC. The radial stem was found to loosen after surgery, leading to pain, fracture, soft-tissue damage, and revision surgery for some patients. Attorneys are investigating product-liability claims against DePuy Synthes and its parent, Johnson & Johnson, alleging the radial stem was defectively designed. The claims involve people who received the implant and later needed medical treatment or another surgery. No lawsuit, class action, or multidistrict litigation has been filed over the device as of September 2026. The matter remains at the attorney-investigation stage for people considering a product-liability claim.

Latest DePuy Synthes Elbow Lawsuit Updates

June 12, 2017: UK Regulator Issues Device Alert

The UK’s MHRA (Medicines and Healthcare products Regulatory Agency) issued Medical Device Alert MDA/2017/016 for the DePuy Synthes Radial Head elbow prosthesis system [1]. It told hospitals not to implant remaining devices and to monitor implanted patients for up to two years, watching for pain, loss of function, or instability that could signal loosening.

February 2, 2017: FDA Classifies the Recall as Class II

The FDA classified DePuy Synthes’s recall of the Radial Head Prosthesis System as a Class II device recall [2]. A Class II recall means the affected device could cause temporary or medically reversible health problems for some patients. The recall, numbered Z-1124-2017, covered the surgical part numbers used to implant and revise the radial head component, and it formally closed on February 6, 2018.

December 29, 2016: DePuy Synthes Recalls the Radial Head Implant

Synthes (USA) Products LLC initiated a nationwide recall of about 50,311 units of the Radial Head Prosthesis System after finding the radial stem could loosen after surgery, the same recall the FDA classified above. DePuy Synthes mailed consignees an Urgent Notice explaining the recall and asked them to review their inventories, complete a verification form, and return any affected product they found.

February 22, 2013: Trial Instrument Recalled over a Separate Loosening Risk

DePuy and Synthes recalled 417 units of the reusable Trial Radial Head, a surgical sizing instrument used during elbow implant surgery, after finding it could come loose from the implant stem while a surgeon manipulated the arm [3]. This recall, numbered Z-1238-2013, covered only the reusable trial instrument rather than the implanted device itself. The FDA record states that no adverse events were reported in connection with it.

What Is the DePuy Synthes Radial Head Prosthesis System?

The FDA classifies the DePuy Synthes Radial Head Prosthesis System as an elbow joint radial, or hemi-elbow, polymer prosthesis under 21 CFR 888.3170, a Class II device [4]. It is used for primary and revision replacement of the radial head. Synthes (USA) Products LLC brought it to market through the FDA’s 510(k) clearance pathway.

Who May Be Affected?

People who received a DePuy Synthes Radial Head Prosthesis System before its December 29, 2016 market withdrawal may be affected by the recall. Those who have since developed pain, loss of function, or instability in the operated elbow match circumstances the UK’s MHRA flagged, as does anyone whose imaging shows stem loosening, osteolysis, or a fracture near the implant. Anyone who needed a second surgery to remove, replace, or repair the implant after these symptoms appeared may also want their case reviewed by an attorney familiar with the recall. Implant part numbers and dates vary by patient, so an individual legal review is the way to confirm whether a specific case matches the recalled device and its timeline.

Reported Injuries or Damages

Implant loosening at the stem-bone interface may lead to osteolysis, poor joint mechanics, bone fracture, or soft-tissue damage, and it can require revision surgery to correct. The same MHRA alert warned that this loosening may lead to these outcomes in patients whose Radial Head Prosthesis System loosened after implantation. It recommended imaging every six months for up to two years to catch loosening early. Complaints in product-liability investigations describe pain, reduced range of motion, and the need for a second operation to remove or replace the failed hardware. This is separate from the smaller Trial Radial Head instrument recall, which reported no adverse events. Only a documented medical record can confirm whether a specific patient’s condition matches these known complications, since a symptom list alone cannot decide that.

Recall and Regulatory Background

Both FDA recalls detailed above are now closed actions, and a recall does not automatically establish liability or eligibility for compensation. The UK’s MHRA separately warned providers against implanting any remaining devices and to keep watching patients who already received one.

Evidence to Preserve

Anyone considering a product-liability claim over the DePuy Synthes Radial Head Prosthesis System should gather and keep the following evidence, since it can support a later individual legal review:

• Medical records documenting the implant surgery, follow-up visits, and any revision surgery
• Imaging, such as X-rays, showing stem loosening, osteolysis, or a fracture near the implant
• The implant’s part number or lot number, or the explanted hardware itself if it was returned
• Correspondence with the surgeon, hospital, or DePuy Synthes about the device or its recall
• Records of related medical expenses, lost income, or other out-of-pocket costs

Saving this evidence early, before records are discarded or an implant is disposed of, makes it easier for a lawyer to evaluate a potential claim.

Filing Deadlines

Filing deadlines for a product-liability claim come from state law rather than one nationwide rule, and each state sets its own filing window. How much time a person has can depend on where they live and when the injury, or its diagnosis, occurred. Some states start the clock at diagnosis rather than at surgery. Missing the deadline that applies to a specific case can end it regardless of its merits, so anyone considering a claim should speak with a lawyer promptly.

Potential Compensation

People who successfully pursue a claim over the DePuy Synthes Radial Head Prosthesis System may potentially recover certain categories of damages, depending on the facts of their case. These can include medical expenses, lost wages, pain and suffering, and the cost of revision surgery, among other losses tied to the implant’s failure. No settlement or public verdict has been reported for this device as of September 2026, and no timeline for one has been set. Compensation amounts vary by case. Past results do not guarantee future outcomes. A lawyer can explain how any potential compensation might apply here.

Frequently Asked Questions

What Complications Have Been Reported with the DePuy Synthes Radial Head Implant?

Reported complications with the DePuy Synthes Radial Head Prosthesis System include stem loosening, osteolysis, joint problems, fracture, and soft-tissue damage. The FDA tracked the 2016 device recall under Event ID 76182, separate from Event ID 64771 for the earlier 2013 trial-instrument recall.

Where Is Synthes (USA) Products LLC, the Company Behind the Recall, Located?

Synthes (USA) Products LLC, the FDA’s listed recalling firm for the DePuy Synthes Radial Head Prosthesis System, is located at 1301 Goshen Parkway in West Chester, Pennsylvania, according to the agency’s recall record.

How Long Do I Have to File a DePuy Synthes Elbow Lawsuit?

How long you have to file a DePuy Synthes elbow lawsuit is set by your state’s law rather than the date a recall closed, such as the 2013 recall’s August 31, 2015 termination. Contacting a lawyer soon after diagnosis helps protect the claim.

What Should I Do If My DePuy Elbow Implant Is Failing?

If a DePuy Synthes elbow implant seems to be failing, see an orthopedic surgeon for an evaluation and imaging first. Keep records of that visit and the implant’s part number. DePuy Synthes lists 610-719-5000 as a customer support contact for questions about the recalled device.

What Does the Research Say About DePuy Synthes Elbow Implant Failures?

Research on DePuy Synthes elbow implant failures points to post-operative loosening at the stem-bone interface as the central problem. The UK’s MHRA found this could lead to osteolysis, fracture, or soft-tissue damage requiring revision surgery in implants from catalog series 03.402 and 04.402.

Does the 2013 Trial Instrument Recall Affect My DePuy Synthes Implant?

The 2013 recall does not affect a DePuy Synthes Radial Head Prosthesis System that is still implanted. That earlier recall was filed under FDA establishment number 3005180112 and covered only the reusable Trial Radial Head rather than the permanent implant, which was recalled separately under establishment number 3008812560 in 2016.

References

1. https://assets.publishing.service.gov.uk/media/593e5d3140f0b63e0b000247/MDA-2017-016_FinalFinal.pdf
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117017
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KWI