Kinemax Plus Revision TS Tibial Inserts 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2008/066

CON025818

2008-09-18

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON025818

Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect. patients with revision knee replacements may have received a tibial insert with a manufacturing defect. the affected devices have an incorrectly machined stabiliser post recess, which prevents the tibial insert from fitting correctly over the stabiliser post. the manufacturer has contacted all uk users to recall the affected devices (see the manufacturer’s field safety notice in appendix). 112 affected devices were distributed in the uk. as a result of the recall, 73 unused devices have been returned to the manufacturer. the remaining 39 devices may have been implanted in patients. patients who have received these implants are at risk of loosening, excessive wear and/or fracture of components. these could be caused by any of the following reasons: the gap between components was not detected during assembly excessive force was required to seat the insert with the base plate a smaller stabiliser post from a smaller sized insert was used to complete the surgery.

Do not implant affected devices Identify any affected stock that has not been implanted, and return to manufacturer Follow the patient management recommendations in this alert. Do not implant affected devices Identify any affected stock that has not been implanted, and return it to the manufacturer Identify which patients have been implanted with affected devices Ensure that affected patients, including those without symptoms, are followed up in accordance with usual standards of care for revision knee replacement patients (the manufacturer recommends follow-up at 6 weeks, 6 months, 12 months, and annually thereafter) Advise patients implanted with affected devices to report any increasing pain, or any symptoms of knee instability such as clicking Consider the need for revision for symptomatic patients.