The Health Products Regulatory Authority (HPRA) have posted a product recall for a DePuy Shoulder System.
The shoulder system that is being recalled is the “Global Unite Platform Shoulder System”. The system is intended for total or hemi shoulder arthroplasty, which is a partial or full shoulder replacement. The recall is published on the HPRA website.
Reason for the Recall
DePuy Ireland have determined that select batches of the Global Unite stem may have an undersized spigot board diameter, which may impact negatively on the patient in the form of surgical delay and/or bone damage. In simple terms, it appears that the parts of the metal elements used in the manufacture of the shoulder replacement were not assembled correctly and could cause complications if used or left in.
The device is being recalled as screws in specific lots of the global unite anatomic body and Global Unite fracture body were inverted during assembly to the body. This will cause the humeral stem to sit proud and may cause surgical delays.
DePuy Orthopaedics is voluntarily recalling 11 lots of the Global Unite Platform Shoulder System.
Potential Impact for Patients
DePuy Ireland have confirmed that surgical delay may occur if another stem needs to be obtained to finalise the procedure and have warned that there is potential for bone damage.
The company has also advised that health care providers who have treated patients using the system should continue to follow those patients pursuant to the Health Care Providers Standard of Care. No adverse events have been reported for this issue so far.
If you are concerned that you have had the DePuy Global Unite Platform Shoulder System used for a total or hemi shoulder arthroplasty, you should contact your Consultant Orthopaedic Surgeon to discuss whether you require revision surgery.
Should you require any advice in relation to these matters please do not hesitate to contact us.