DePuy Synthes elbow implants recalled by the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for radial head elbow artificial replacements amidst concerns over post-operative loosening of the device.

Manufactured by DePuy company Synthes, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved Radial Stem implants are both affected by the recall. The recall follows on from a Field Safety Notice (FSN) issued back in December 2016 by the company’s Senior Quality Assurance Manager, Anne Brisson.

The FSN notified relevant health providers of the issues and the imminent recall. Instructions were provided to stop using the implants until Synthes can narrow down the cause of the loosening.

As the medical device manufacturer has been unable to identify the cause of the loosening, they’ve had no choice but to recall all the “DePuy Synthes Radial Head Prosthesis Stem from the global market”.

Artificial elbow joints

The prostheses acts as an artificial joint in the elbow where soft cartilage in the elbow joint has been worn away or damaged by a bad fracture. The devices look like large screws with a smooth concave surface to allow the joining bone to move free of friction.

The stem of the devices are inserted inside the radius bone with a textured surface that encourages bone growth for the natural bone to envelope the stem. Unfortunately, for reasons still unknown to the company, the devices can become loose and cause pain, and problems with mobility, for the patient.

All patients to be notified

All patients who have had the implants inserted are to be notified of the recall, and healthcare providers are advised to keep an eye on patients for any problems or changes. Patients with problems may suffer symptoms like:

As the medical device alert is not classed as extremely serious, patients who already have the implants are not required to have replacement surgery, but it’s recommended for those suffering from symptoms like those mentioned above to seek advice. Healthcare institutions are encouraged to monitor patients every six months for up to two years after having the DePuy prosthetic inserted.

The loosening of the prostheses may lead to all sorts of problems including:

Patients must not hide symptoms and must inform healthcare practitioners of any issues in order to prevent any lasting injuries that may have a life-changing effect. Thankfully, there have been no reports of adverse effects at the time of issuing the medical alert (12^th June 2017).

Whilst it has not yet been disclosed how many of the implants are out there, or have already been implanted, the recalled devices have only been on the market for less than two years. However, the recall is for all lots and batches of the affected implants.

The medical device alert also requests practitioners find and return affected products back to DePuy Synthes and notify the company of any problems any implanted patients have suffered.