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 의 리콜

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.