Events

Field Safety Notices about Optipac bone cement

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 Zimmer Biomet.

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
  • Date
    2016-11-15
  • 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
    Optipac complaints were reviewed. the reported complaint rate for optipac is 0.0004% (for infections). it is up to the medical professional to evaluate whether a patient needs to be examined, but current results do not appear to require additional controls beyond the 2e standard.

Device

Optipac bone cement
  • Model / Serial
    Optipac Hipset Optipac 40 Refobacin Bone Cement R Optipac 60 Refobacin Bone Cement R Optipac 80 Refobacin Bone Cement R Optipac Softpac Hipset Optipac-S 40 Refobacin Bone Cement R Optipac-S 60 Refobacin Bone Cement R Optipac-S 80 Refobacin Bone Cement R Optipac Knee Refobacin Bone Cement R Optipac 40 Refobacin Plus Bone Cement Optipac 60 Refobacin Plus Bone Cement Optipac 80 Refobacin Plus Bone Cement Optipac-S Knee Refobacin Bone Cement R Optipac Softpac Refobacin Revision 40 Optipac-S 60 Refobacin Plus Bone Cement Optipac-S 80 Refobacin Plus Bone Cement Optipac Knee Refobacin Plus Bone Cement Optipac Refobacin Revision 40 Optipac Refobacin Revision 80 Optipac-S Knee Refobacin Plus Bone Cement Optipac-S 40 Refobacin Plus Bone Cement Optipac-S Refobacin Revision 80
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    AMPMDRS