The Union health ministry has issued alert on the Johnson & Johnson subsidiary DePuy Orthopaedics Inc's defective medical device ASR XL Acetabular System & DePuy ASR Hip Resurfacing system which is used in hip replacement surgeries for people with hip joint damage from arthritis or injuries.
The ministry's action comes after the recall of ASR hip replacement implants due to increased rates of revision.
In the alert, the ministry has asked the medical directors, healthcare professionals, orthopaedic surgeons and other staff involved in the management of patients with joint replacement implants not to implant DePuy ASR hip replacements and to return all unused ASR hip replacement implants to the manufacturer. The government has also asked them to inform all patients implanted with ASR hip replacements about this recall and schedule them for a follow-up visit.
The ministry has also asked the healthcare professionals to conduct follow up all patients implanted with ASR hip replacements with clinical examination at least annually.
For patients presenting with symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality, the ministry has directed the healthcare professionals to consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scan.
If metal ion levels in whole blood are elevated above 120 nmol/L (cobalt) or 135 nmol/L (chromium) [ie seven parts per billion (ppb) for either metal ion], a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging. If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses then consider revision surgery, the ministry said in its alert.
The government has also advised the patients and healthcare professionals to report adverse events suspected to be associated with the ASR XL Acetabular System & DePuy ASR Hip Resurfacing system or other medical device to the manufacturer and CDSCO.
So far, 15,829 units of ASR XL Acetabular System & DePuy ASR Hip Resurfacing system have been imported in India of which 1295 unused product has been returned to the company.