Based on the recommendations from the French manufacturer, Saint Gobain, Zimmer is advising its customers that there is a possibility for breakage of zirconia ceramic femoral heads, part of the prosthesis used in total hip arthroplasties or replacements.
Zimmer had voluntarily recalled these items in August 2001, although they have been available since 1999. While the only items that appear to pose a risk come from a single batches accounting for 234 units, Zimmer has opted to recall another eight batches. It is believed that if faulty, the items are most likely to fail in the next few years. Thus far, only four failures have been reported and the units in question make up less then 0.1% of all hip replacements carried out using Zimmer materials.
Zimmer has also advised surgeons who have implanted the devices to follow the progress of their patients and is providing the surgeons with detailed updates for the benefit of the recipients.
0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home