Consumers and health professionals are advised that Allegra Orthopaedics, in consultation with the TGA, is issuing a hazard alert regarding a higher than expected revision rate for its Active Total Knee Replacement System when patella resurfacing has not been undertaken during implantation.
Knee implants are made up of various components which can be used in a variety of configurations. One option is to use a 'button' to 'resurface' the back of the patient's patella and keep it from potentially rubbing against the implant as the knee bends.
An analysis of data in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 2015 Report shows that the revision rate for implants using certain Active Total Knee Replacement System components have a higher revision rate than expected when compared with similar implants and this appears to be related to a lack of patella resurfacing.
Information for consumers
If you or someone you provide care for has received an implant using the Active Total Knee Replacement System, be aware of this issue.
If you are not sure what type of knee replacement you have or if you have concerns about your knee replacement, you should seek information from the orthopaedic surgeon who performed the operation or the hospital where the operation was performed.
Contact your general practitioner/surgeon if you experience any of the following symptoms at the site of your knee replacement:
Information for health professionals
If you are treating someone who has received an implant using the Active Total Knee Replacement System, be aware of this issue.
Patients with any knee replacement should be followed up by the implanting surgeon if they complain of pain, swelling or instability in their knee.
Information for orthopaedic surgeons
Allegra Orthopaedics has contacted surgeons who have used the Active Total Knee Replacement System providing further information about this issue.
A review of data in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 2015 Report shows that the Active Knee Femoral Component used with the Active Knee Tibial Component (cemented or cementless) has a higher revision rate than expected when compared to similar implants. A large number of the revisions were due to patella breakage – a problem that has been addressed in recent years (the TGA issued an alert regarding that issue in 2012). However, further analysis of the information held by the AOANJRR indicates that use of the Active Knee Total Knee Replacement Prosthesis without patella resurfacing at the time of primary surgery may lead to increased risk of patella erosion and patella-femoral pain.
Allegra Orthopaedics advises that the device can continue to be used. However, Allegra Orthopaedics strongly recommends that patella resurfacing is performed at the time of primary surgery when an Active Total Knee Replacement Prosthesis is used.
Allegra Orthopaedics has issued the following advice to surgeons who have used Active Total Knee Replacements to ensure continued safe use and proper patient management.
For prospective patients:
- It is strongly recommended that patella resurfacing is performed when Active Total Knee replacement femoral components are used.
- Use of the Active Femoral Component otherwise may proceed as normal.
For patients who have received the Active Femoral Component without patella resurfacing:
- Asymptomatic patients do not require surgical intervention as a result of this alert.
- Particular consideration for the increased risk of patella erosion and patella-femoral pain will need to be paid to patients at follow-up visits.
- The surgeon may consider more careful or frequent follow-up.
Affected components are:
|ARTG number||Description||Catalogue numbers|
|217122||Active Knee (Cemented) Femoral Component||10-1521-0342 to 10-1522-0270|
|133900||Active Knee (Cementless) Femoral Component||10-1521-0302 to 10-1522-0230|
|217127||Active Knee (Cemented) Tibial Component||10-1513-0500 to 10-1513-0509|
|217128||Active Knee (Cementless) Tibial Component||10-1513-0400 to 10-1513-0409|
|217306||Active Knee Patella||10-1514-0750 to 10-1514-0754|
|217305 & 217297||Active Knee Knee Insert/Bearing||10-1533-0080 to 10-1533-0275|
If you have any questions or concerns about this issue, contact Allegra Orthopaedics on 1800 644 370 or email firstname.lastname@example.org.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.