Action underway: 4 June 2014, action complete: 12 June 2014
Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and testing.
Unicondylar sled knee prosthesis
Metal-backed tibial plateau Endo-Model® 7mm
Manufactured by Waldemar Link GmbH & Co. KG
Catalogue numbers: 15-2030/01, 15-2030/05 and 15-2030/09.
The metal-backed tibia plateau consists of a UHMWPE (plastic) part attached to a cobalt-chromium alloy (metal) plate. The total height of the tibial plateau is 7 mm.
Risk of early wear of the ultra high molecular weight polyethylene (UHMWPE) plastic part of the tibial plateau of this device.
In August 2013 Waldemar Link issued a Field Safety Notice informing clinicians that they had received reports of wear of the plastic part of the metal-backed tibial plateau Endo-Model® 7mm.
The manufacturer has informed the MHRA that the affected products have now been discontinued.
A total of 9 cases of wear of the plastic part of the device were reported to the manufacturer from outside of the UK. The implant failures occurred between 6 months and 5 years after implantation and analysis of the returned explants showed significant plastic wear. A definitive root cause for the wear events has not been determined by the manufacturer.
Wear of the plastic part of the plateau could lead to pain and stiffness. The debris generated by the wear could cause osteolysis, requiring device revision. In instances where wear leads to metal-on-metal contact, the resulting wear debris may lead to soft tissue damage requiring device revision.
442 devices were distributed in the UK between 2003 and 2013.
The MHRA is issuing this Medical Device Alert to ensure that clinicians are aware of this issue and consider appropriate follow up of patients implanted with affected devices.
Identify patients implanted in the last 5 years with these devices.
Consider annual review of patients for up to 5 years after implantation, including X-rays* to detect progression of bearing wear.
Retain explanted devices to facilitate investigation by the manufacturer.
Report all adverse events to the MHRA and to Waldemar Link.
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
Staff involved in the management of patients with joint replacement implants
This MDA has been sent to:
Clinical commissioning groups (CCGs)
Care Quality Commission (CQC) (headquarters) for information
HSC trusts in Northern Ireland (chief executives)
Local authorities in Scotland (equipment coordinators)
NHS boards and trusts in Wales (chief executives)
NHS boards in Scotland (equipment coordinators)
NHS England area teams for information
NHS trusts in England (chief executives)
Please bring this notice to the attention of relevant employees in your establishment.
Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
Hospitals in the independent sector
Independent treatment centres
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: email@example.com and requesting this facility.