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    Item type:Publication, Access status: with files ,
    Mandatory labelling of CMR substances in implants and their impact on orthopedics and trauma surgery
    (Thieme, 2026-02-13)
    Birkholz, Jan
    ;
    Roos, Jonas
    ;
    Hasselbach, Hannes
    ;
    Preißler, Reinhold
    ;
    Michel, Marc D.
    With the commencement of EU Regulation 2017/745 (Medical Device Regulation, MDR), a justification and labelling obligation for medical devices was introduced for substances (chemicals, elements) that are proven or suspected to be carcinogenic, mutagenic or toxic to reproduction (CMR substances). This also applies to substances having endocrine disrupting properties. This obligation has led to great concern in the industry and among medical professionals, particularly with regard to possible uncertainty on the part of patients and users. The aim of this article is to clarify the most important context in order to counteract these concerns. For patients, the CMR labelling requirement will not result in any changes in the quality of care. On the other hand, the medical profession has the additional task of conveying a sense of security to their patients despite an uncontrollable public debate. The use of a ceramic head instead of a metal head in hip joint replacement can be cited as an example here. CMR-labelled implants pose only a very low risk to the patient due to the material, which only occurs in very rare cases if the restoration fails. In the future, however, manufacturers must aim to qualify more CMR-free materials. However, this is a cost- and time-intensive endeavour under the regulations of the MDR with high requirements, particularly with regard to clinical efficacy. The well-established tried-and-tested implant materials have proven to be clinically successful even in difficult revision situations. Switching completely to a different material without the corresponding clinical experience could potentially lead to losses in component safety. The implementation of the CMR labelling requirement should be closely monitored by both the medical profession and manufacturers in order to counteract any uncertainty among patients at an early stage.
    Publicationtype: Review Article
      14  25
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    Item type:Publication, Access status: with files ,
    Explant analysis and implant registries are both needed to further improve patient safety
    (The British Editorial Society of Bone & Joint Surgery, 2022-05-31)
    Morlock, Michael
    ;
    Gomez-Barrena, Enrique
    ;
    Wirtz, Dieter Christian
    ;
    Hart, Alister
    ;
    Kretzer, Jan Philippe
    In the early days of total joint replacement, implant fracture, material problems and wear presented major problems for the long-term success of the operation. Today, failures directly related to the implant comprise only 2–3% of the reasons for revision surgeries, which is a result of the material and design improvements in combination with the standardization of pre-clinical testing methods and the post-market surveillance required by the legal regulation. Arthroplasty registers are very effective tools to document the long-term clinical performance of implants and implantation techniques such as fixation methods in combination with patient characteristics. Revisions due to implant failure are initially not reflected by the registries due to their small number. Explant analysis including patient, clinical and imaging documentation is crucial to identify failure mechanisms early enough to prevent massive failures detectable in the registries. In the past, early reaction was not always successful, since explant analysis studies have either been performed late or the results did not trigger preventive measures until clinical failures affected a substantial number of patients. The identification of implant-related problems is only possible if all failures are reported and related to the number of implantations. A system that analyses all explants from revisions attributed to implant failure is mandatory to reduce failures, allowing improvement of risk assessment in the regulatory process.
    Publicationtype: Journal Article
    Scopus© Citations 1  46  96