This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 A second-degree burn after radiofrequency chondroplasty was reported in the US Food and Drug Administration's (FDA) manufacturer and user facility device experience (MAUDE) database. This was attributed to improper use of the radiofrequency equipment: a suction line, which should have been attached to the probe during the procedure, had not been attached.
5.2 Osteonecrosis of the medial femoral condyle was observed in 4% (2/50) of patients at a follow-up assessment that occurred at least 6 months after treatment, in a prospective case series of 50 patients. No clinical consequences were reported as a result of this.
5.3 The confirmed or presumed detachment of a mechanical component of the radiofrequency probe within a patient's knee was reported on 7 occasions between 2002 and 2012 in the MAUDE database.
5.4 The specialist advisers stated that theoretical adverse events include excessive debridement of articular cartilage, avascular necrosis of the underlying bone, chondrocyte death and damage to surrounding cartilage and other structures.