Retiro De Equipo (Recall) de balanSys Knee System (CR, UC, PS and RP) balanSys Bone Orientated 4in1 SMaRT Instruments, balanSys BICON Knee System Template, balanSys PS Knee System Template, balanSys PE Trial Inlay 67/8-20.5, balanSys PE Trial Inlay 67/8-23, balanSys CR/PS Tibial Template 67, balanSys RP Trial Tibial Plateau 67

Recall

RC-2014-RN-00094-1

Class II

2014-01-31

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00094-1

The incorrect size determination table in surgical technique indicates that the femoral component size c is compatible with a tibial inlay/tibial plateau size 67. however, tibial components size 67 may be correctly used only with the smaller femoral components sizes a or b. the incompatible combination of the balansys cr, uc and ps systems (fixed bearing)may result in the following risks: - there is an immediate risk that the knee cannot be optimally equilibrated, which may lead to pain and instability. - in the long term, there is a risk of increased wear of the polyethylene, which may lead to pain, osteolysis, tibial loosening, instability and revision surgery. in the balansys rp system (rotating platform), there is a risk of increased soft-tissue irritation associated with pain.

Mathys Orthopaedics is advising surgeons and hospitals that the Surgical Technique is incorrect as it indicates that the femoral conmponent size C is compatible with a tibial inlay/tibial plateau size 67. Tibial components size 67 should only be used with smaller femoral components size A and B. A single patient was implanted with the incorrect combination in Australia. The associated surgeon has been contacted and provided with additional information for the ongoing management of the patient.