ADEPT® 12/14 modular head 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2013/010

CON249611

2013-03-12

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON249611?tabName=allTabs

Higher than expected revision rate for the adept® 12/14 modular head components when used in a total hip arthroplasty. analysis of data from the national joint registry (njr) for england and wales since 11 november 2012 has shown a higher than expected cumulative revision rate for the adept® 12/14 modular head when used in conventional total hip arthroplasty (12.1% at seven years). further information on the revision rates for specific stems used with the adept® 12/14 modular head can be found in depuy’s field safety notice recalling the affected modular heads (issued 15 january 2013).

Do not implant ADEPT® 12/14 modular head devices. Return all affected devices to DePuy International Ltd. Follow up both symptomatic and asymptomatic patients implanted with these devices in line with recommendations in the table on page 2. Report all adverse incidents to the MHRA and DePuy International. Medical directors. Orthopaedic departments. Orthopaedic surgeons. Staff involved in the management of patients with joint replacement implants.   Stemmed MoM total hip replacements – femoral head diameter ≥36mm   Symptomatic patients Asymptomatic patients Patient follow-up Annually for the life of the implant Annually for the life of the implant Imaging: MARS MRI or ultrasound Recommended in all cases Recommended if blood metal ion levels rising 1st blood metal ion level test Yes Yes Results of 1st blood metal ion level test Blood metal ion level >7ppb indicates potential for soft tissue reaction If blood metal ion level >7ppb then second blood test required 3 months later 2nd blood metal ion level test Yes - 3 months after 1st blood test  if  result was >7ppb Yes - 3 months after 1st  blood test if result was  >7ppb Results of 2nd blood metal ion level test Blood metal ion level >7ppb indicates potential for soft tissue reaction especially if greater than previously If blood metal ion levels rising - further investigation required including imaging Consider need for revision If  imaging is abnormal and/or blood metal ion levels rising If  imaging is abnormal and/or blood metal ion levels rising Table footnotes: Blood metal ion testing to be in whole blood. 7 parts per billion (ppb) equals 119 nmol/l cobalt or 134.5 nmol/l chromium. Measurements of cobalt or chromium ions should be carried out: in England, Northern Ireland or Wales, by laboratories participating in the Trace Elements External Quality Assessment Scheme (TEQAS)  -  http://www.sas-centre.org/home.html in Scotland, by the Scottish Trace Element and Micronutrient Reference Laboratories - Scottish Trace Element and Micronutrient Reference Laboratory  -  http://www.trace-elements.co.uk/ Guidance notes: On the basis of current knowledge, this chart has been produced as a guide to the management of these patients. It will not necessarily cover all clinical situations and each patient must be judged individually. MARS MRI scans (or ultrasound scans) should carry more weight in decision making than blood ion levels alone. Patients with muscle or bone damage on MARS MRI are those of most concern. A fluid collection alone around the joint in an asymptomatic patient, unless it is very large can be safely observed with interval scanning. Local symptoms include pain and limping.