Comprehensive Reverse Titanium Shoulder Tray (specific lots) - risk of device fracture
- Medicines and Healthcare products Regulatory Agency
- 4 April 2017
- 4 April 2017
- Alert type:
- Medical device alert
- Medical speciality:
- General practice, Orthopaedics, and Theatre practitioners
Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
- Do not implant Comprehensive Reverse Shoulder Humeral trays from the lots listed in the manufacturer’s field safety notice (FSN)
- Locate and return all affected products to Zimmer Biomet
- Identify all patients implanted with the affected device and inform them of this issue
- Advise patients to contact their orthopaedic surgeon if they develop symptoms such as pain, swelling, dislocation or a change in shoulder shape or function
- Symptomatic patients should be investigated, which may include imaging such as x-ray to identify a possible fracture of the device
- Report all adverse events involving the Comprehensive Reverse Shoulder humeral tray to Zimmer Biomet and to MHRA or the appropriate Devolved Administrations
In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of the Ionising Radiation (Medical Exposure) Regulations 2000.
- Medical directors
- Orthopaedic departments
- Orthopaedic surgeons
- Staff involved in the management of patients with joint replacement implants
Deadlines for actions
Actions underway: 25 April 2017
Actions complete: 27 June 2017
Problem / background
In December 2016, Zimmer Biomet issued an FSN informing clinicians of the higher than anticipated rate of fracture of titanium Comprehensive Reverse Shoulder Humeral Trays manufactured prior to September 2011. The affected products were distributed between September 2010 and January 2017.
The mean time to fracture is approximately 3 years. The clinical symptoms of device failure include pain, swelling, loss of function and dislocation of the shoulder prosthesis.
MHRA is issuing this alert to ensure that clinicians are aware of this issue and consider appropriate follow-up of patients implanted with affected devices.
Waterton Industrial Estate
Tel: 01656 761 658
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Orthopaedic surgeons
- Outpatient clinics
- Supplies managers
- Theatre managers
- Theatre nurses
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
Establishments registered with the Care Quality Commission (CQC) (England only):
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/005 or 2016/012/030/701/004.
Jillan Hussein, MHRA
Tel: 020 3080 7148
MHRA Devices Clinical Team
Tel: 020 3080 7274
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 4 April 2017
Issued: 4 April 2017
Alert type: Medical device alert