Friday, December 31, 2010

Recall notice sent by Depuy to the orthodpedic surgeons

Full text of the letter can be found here:
http://www.depuy.com/sites/default/files/DPYUS1%20Recall%20Notice.pdf

Excerpts:

 DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASR™ System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter).

 DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent and for the ASR™ XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patient.

 Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products.

 Do not implant the ASR devices.

 Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome.

For patients who are symptomatic or implanted with a cup angle greater than 45°, particularly where a small component has been implanted:
o Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scans
o If metal ion levels in whole blood are elevated above 7 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
o If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.

Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery.

connie

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