Events

Field Safety Notices about SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by DePuy Synthes.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    At depuy orthopedics, inc., we have decided to voluntarily recall ten batches of sigma® high performance (hp) mbt non-keel punch knee instrument (see figure 1). please stop distributing and using contested lots. we challenged the challenged product series because of a change in design that resulted in an unanticipated increase in the height of the instrument. therefore, it is possible for the surgeon to choose an implant that is too narrow during the trial implant placement procedure (see figure 2).

Device

SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument

Manufacturer

DePuy Synthes