It comes to our attention that medical device manufacturer, DePuy (a Johnson & Johnson company) has issued a field safety notice concerning DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems.
In 2007, DePuy issued a letter to Ultima TPS cemented polished Cobalt Chromium (CoCr) hip stem users in the United Kingdom (UK) to inform them of a potential association between extensive peri-prosthetic soft tissue necrosis and hip stem implantation with the Ultima Metal-on Metal (MoM).
Following research activities undertaken by DePuy, it was concluded that when used in combination with a MoM articulation of an all metal type, DePuy's cemented, polished, CoCr femoral hip stems, including the DePuy G2 and FJORD Cemented Femoral Hip Stems could potentially exhibit corrosion of the polished surfaces which are within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Therefore, DePuy advises against the implantation of the following configuration: DePuy's cemented, polished, CoCr alloy femoral hip stems combined with MoM articulation.
According to the local supplier, Ultima TPS, DePuy G2 and FJORD Cemented Femoral Hips Stems have not been distributed in Hong Kong. If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 03 May 2012