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  • Author: Liza N van Steenbergen x
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Richard N de Steiger, Brian R Hallstrom, Anne Lübbeke, Elizabeth W Paxton, Liza N van Steenbergen, and Mark Wilkinson

  • Recent concerns surrounding joint replacements that have a higher than expected rate of revision have led to stricter controls by regulatory authorities with regards to the introduction of new devices into the marketplace.

  • Implant post-market surveillance remains important, and joint replacement registries are ideally placed to perform this role. This review examined if and how joint replacement registries identified outlier prostheses, outlined problems and suggested solutions to improve post-market surveillance.

  • A search was performed of all joint replacement registries that had electronic or published reports detailing the outcomes of joint replacement. These reports were examined for registry identification of outlier prostheses. Five registries publicly identified outlier prostheses in their reports and the methods by which this was performed, and three others had internal reports.

  • Identification of outlier prostheses is one area that may improve overall joint replacement outcomes; however, further research is needed to determine the optimum methods for identification, including the threshold, the comparator and the numbers required for notification of devices.

  • Co-operation of registries at a global level may lead to earlier identification of devices and thereby further improve the results of joint replacement.

Geke A. W. Denissen, Liza N. van Steenbergen, Wouter T. Lollinga, Nico J. J. Verdonschot, Berend W. Schreurs, and Rob G. H. H. Nelissen

  • In the Dutch Arthroplasty Register (LROI), the product and batch number of prosthetic components and cement are registered for traceability. Registration of the product number provides opportunities to extend the information about a specific prosthesis. All product numbers used from the beginning of the registration in 2007 were characterized to develop and maintain an implant library.

  • The Scientific Advisory Board developed a core-set that contains the most important characteristics needed to form an implant library. The final core-set contains the brand name, type, coating and material of the prosthesis. In total, 35 676 product numbers were classified, resulting in a complete implant library of all product numbers used in the LROI.

  • To improve quality of the data and increase convenience of registration, the LROI implemented barcode scanning for data entry into the database. In 2017, 82% of prosthetic components and cement stickers had a GS1 barcode. The remaining product stickers used HIBCC barcodes and custom-made barcodes.

  • With this implant library, implants can be grouped for analyses at group level, e.g. evaluation of the effect of a material of a prosthesis on survival of the implant. Apart from that, the implant library can be used for data quality control within the LROI database.

  • The implant library reduces the registration burden and increases accuracy of the database. Such a system will facilitate new designs (learning from the past) and thus improve implant quality and ultimately patient safety.

Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180063