To find specific, detailed information about problems reported with
knee replacement systems, patients may
go to the FDA's
MAUDE Database site.
To find the information, enter the name
of the manufacturer
in the "Manufacturer" field
and click the "Search" button at the bottom of the form. The search return more than 500 matches,
which is the maximum the system can display. So, you will only see 500 results returned.
For more specific information, return to
and enter the product name
in the "Brand Name" field. This will return
a more manageable list, although not comprehensive, due to the way brand names are entered into the system.
For example, the following information about defective Smith and Nephew products is
listed on the FDA's
MAUDE Database site:
Oxinium Femoral Component - Adverse Event or Product Problem - Nov. 7, 2003
Genesis II Oxinium - Adverse Event or Product Problem - Aug. 12, 2002
Genesis II Oxinium - Adverse Event or Product Problem - Mar. 9, 2002
Information about some recalls might not appear on the on-line
FDA Enforcement Report. This
may be due to the voluntary nature of the recalls or due to an on-going evaluation. Patients
fitted with these products may wish to contact the FDA or periodically check the
searchable database for additional information.