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Health professionals and consumers are advised that Advanced Surgical Design & Manufacture (ASDM), in conjunction with the TGA, is investigating elevated failure rates of the patella (knee cap) component of the Active Knee System—an implant used in knee replacement procedures.
Investigations have found that the patella component is failing due to fatigue at the point where the pegs attach to the patella.
ASDM has redesigned the patella component to address the fault. All patellae supplied since 24 June 2012 have included this new design.
Information for consumers
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:
- pain
- swelling
- instability.
Each patient's circumstances are different and the TGA cannot give individual clinical advice regarding the Active Knee System. All therapeutic goods, such as medicines and medical devices, have associated benefits and risks that should be considered in consultation with a health professional.
Information for orthopaedic surgeons
Given the nature of the problem, there is no urgent need to contact patients who have received an Active Knee System. However, it is recommended that those patients be followed up according to their routine protocol and advised of this issue at that stage.
If a patient presents with symptoms of anterior knee pain, swelling of the knee and/or patella instability, then the possibility of a failed patella component should be investigated.
Information for all health professionals
Patients with any knee replacement should be followed up by the implanting surgeon if the patient complains of pain, swelling or instability in their knee.
Additional information
Fourteen failures have been reported to the TGA to date.
Batches that have been found to be affected were manufactured between 2007 and 2011, with failures presenting between one and four years after implantation.
ASDM wrote to orthopaedic surgeons to inform them of this issue on three occasions - in May, November and December 2012.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. 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.