balanSys UNI convex PE inlay x/6, x/7, x/9 의 리콜

Recall

RC-2018-RN-00096-1

Class II

2018-02-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00096-1

Global post market surveillance data showed two (2) reports from 2016 and 2017 concerning in situ inlay breakage of balansys uni convex pe inlays x/6 after approximately eight years. in 2015 mathys ltd bettlach made the decision to phase-out the balansys uni convex unicompartmental knee system based on economic grounds, with only the uni convex pe inlays to be retained to allow for potential minor revision surgeries. the phase out was initiated in december 2015, and completed by december 2016. in november 2016, a field safety corrective action was carried out to recall all balansys uni convex pe inlays x/5 (thickness 5 mm) from the market after the occurrence of seven (7) breakages of the inlays x/5. no events have been reported for x/7 and x/9.

Mathys Orthopaedics is advising surgeons to inform affected patients implanted with a size x/6, x/7 and x/9 inlay about the risks of PE inlay breakage and any further associated potential risks while maintaining their routine follow-up protocol. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of each patients’ clinical circumstances.