Regulatory Filings • Aug 21, 2001
Regulatory Filings
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Corporate | 21 August 2001 09:01
aap Implantate AG english
Corporate-News announcement sent by DGAP. The sender is solely responsible for the contents of this announcement. ——————————————————————————– Statement on product problems among competitors To pre-empt rumors and erroneous reports, aap Implantate AG would like to make an official statement on problems with products that have lately beset competitors in the orthopedics segment. These problems that have arisen in connection with competing products mainly involve cemented titanium hip endoprostheses showing signs of loosening and slight quantities of production residues being found in the highly porous surface structures of hip endoprostheses implanted without using cement. At this time aap has not been affected by either of these problems in any product area. There have, accordingly, been no recalls of products already shipped. What is more, aap is not affected by the recent recall of hip endoprosthesis ceramic heads. Its supplier of hip prosthesis heads is Ceramtec. In the past, loosening has occurred more frequently in the case of hip endoprostheses with a titanium shaft fixed using bone cement than in that of other models. This is because titanium in general reacts sensitively to friction. This phenomenon can, in the case of cemented titanium endoprostheses, lead to the cement casing bursting as a result of the strain imposed by normal movement sequences. aap obviates this state of affairs by making no use whatever of titanium shafts in cemented hip endoprostheses. Its cemented hip endoprostheses are made solely of an alloy of cobalt and chrome, and they are the only materials used in the products that aap sells. In a number of cement-free hip endoprosthesis implants sold by competitors, a porous surface is created on the prosthesis with a view to ensuring a more long- lasting and secure bond between prosthesis and bone. Porous surfaces require particularly intensive cleaning to ensure that no production traces remain in the surface pores. In some cases, hip endoprostheses supplied by other companies have been found to contain production residues in the highly porous surface of the implant that have led to negative post-implant reactions on the patient’s part. At aap Implantate AG, we currently neither manufacture nor market hip endoprostheses with highly porous surfaces. For further information please contact: aap Implantate AG, Gabriele Voßkühler, Investor and Public Relations, Tel.: +49 / (0)30 750 19-133, http://www.aap.de end of message, (c) DGAP 21.08.2001
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