Knee Replacement Device Warnings
knee replacement problems: including Zimmer NexGen CR Flex and Smith & Nephew Oxinium Genesis II and Oxinium Profix II
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Medical Information
Problem reports from the FDA database

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 the form 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.