Aesculap Implant Systems' Orthopaedics Division
As you may already be aware, as of April 1, 2024, Aesculap Implant Systems, LLC. (“AIS”) stopped sales of its orthopedic products in the United States.
To support the needs of existing VEGA System® Knee, Columbus® Knee, and Columbus® AS Revision Knee System patients, AIS will continue in the short term over the next several months to distribute gliding surface and patella polyethylene components for polyethylene component replacement procedures only. AIS will also provide corresponding revision surgery instrumentation sets, as defined within Exhibit A, through your manufacturer’s representative to support the exchange of these components.
AIS-knee systems are no longer available for patients requiring a full revision. During a procedure to replace the gliding surface and/or patella polyethylene components, should you decide that a full revision is necessary, a non-AIS knee system would need to be available for use.
Applicable Labeling Provisions and Information
Refer to the VEGA System® Knee Implant System, Columbus® Knee System, and Columbus® AS Revision Knee System Instructions for Use for applicable information on revision procedures.1 As noted in the “WARNINGS and POTENTIAL RISKS” section of the applicable Instructions for Use, “the mixing of different manufacturer implant components is not recommended due to metallurgical, mechanical and functional reasons. … Do not use implants or instruments from other systems or manufacturers, and do not mix cobalt chromium and titanium implant components together in a total knee system.” Copies of the Instructions for Use are available at https://www.aesculapimplantsystemsifus.com.
Gliding surface and/or patella polyethylene replacement components and associated revisions tool sets may be requested by contacting an AIS manufacturer’s representative, AIS SetWorld Customer Service at (314) 551-5998, or (866) 229-3002 or emailing setworldorders.us@aesculapimplants.com.
To meet its regulatory post-market surveillance obligations, your manufacturer’s representative and/or AIS may be contacting you to obtain additional information about the revision surgery. AIS asks that you keep and store any explanted implants should AIS ask for them to be returned to the company for purposes of explant evaluations to meet its government regulatory obligations.
1Only instruments and components necessary to performing polyethylene component replacement procedures will be provided in the instrument set.