Safety Alert for POLISHED IMPLANTS PACKAGING IN LPDE BAGS: 1. Unrestricted femoral component with coating - Registration Number: 80245480043 - Hazard Class III - See Annex. ////. 2. Cemented femoral rods - Registration Number: 80245480038 - Risk Class III - See Annex. ////. 3. Femoral component with uncoated restriction - Registration Number: 80245480041 Hazard Class III - See Annex. ////. Unrestricted femoral component without coating - Registration Number: 80245480057 - Risk Class III - See Annex.

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 company informs that despite the low potential risk of this LPDE enclosure adhere to the polished surfaces, the manufacturer Zimmer Biomet is collecting the potentially affected products remaining in the stock. The company concluded that the adhesion of the LPDE bag is unlikely to cause a detrimental effect on the patient or the function of the implant. This conclusion is based on the following considerations: 1. LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). /// 2. LPDE is less hard than the two UHMWPE and cobalt-chromium molybdenum combination materials and therefore, no additional damage or wear is expected on the implant surfaces. /// 3. If there are wear particles generated from the adhered LDPE film or shell residue, similar biological reactions would be expected with those of UHMWPE that do not increase the likelihood of peri-prosthesis osteolysis.