The body that regulates medicines, medical devices and blood components for transfusion in the UK has today issued a Medical Device Alert (MDA/2019/006) because Stryker GmbH, the manufacturer of a prosthetic elbow has identified the possibility of post-operative loosening across its entire rHead Radial Head and Uni-Elbow System.
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the alert as a follow up to the manufacturers Field Safety Notice that they issued in November 2017 initiating a voluntary product removal of the system. Stryker GmbH said that the data available to it was found to be inconclusive to continue supporting the device and highlighted the following problems postoperatively including:
- Implant loosening (septic and aseptic),
- instability (moderate and severe),
- stress fracture,
- cyst formation,
- heterotopic ossification
As a result of the Field Safety Notice, the company has removed the Stryker rHead Radial Head and Uni-Elbow System from the global market.
The MHRA has issued the alert to ensure all hospital are aware of the recall and advise against the use of the implant. In addition it advises all patients who have been implanted with the device to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability.
In 2017, 668 elbow replacement procedures were performed in the UK according to the National Joint Registry. 96% were performed by the NHS and 4% were carried out privately.
Hugh James is currently representing several hundred people in their claims against DePuy International Ltdin respect of the DePuy ASR hip prostheses. We are also investigating other medical devices including another elbow prosthesis, the DePuy Synthes Radial Head Prosthesis System and the Smith and Nephew Oxinium Genesis II artificial knee.
If you have had an elbow replacement and have developed symptoms of pain, loss of function or instability you may be eligible to make a claim against the manufacturer.