Alerta De Seguridad para Product Name: Hip Arthroplasty System - Hybrid //. Risk class: III (High Risk) //. Technical name: Modular system for total arthroplasty //. Registration number: 10417940085 //. Affected Model (s): Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx) Lot (s): Various //. Products manufactured before 08/25/2016 - Check affected Codes / Batches

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

The MDT recommends: 1. Locating in the company the aforementioned lots and stocking these lots, performing immediate segregation and sending them to MDT, through a Return Invoice; 2. Locate the batches that have been used in the surgical procedure and inform the implantation data, as requested in the Traceability Monitoring. Recommendations to Users and Patients: If there is any adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product), it should be reported to the Distributor and MDT. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link