A critical appraisal to the decision by the company Zimmer Biomet to withdraw the MaestroTM Wrist Reconstructive System from the marketplace

Abstract

Note by the author: 75% of 104 Scientific References related to TWA are not older than 10 years, and 81% of them are not older than 5 years. Case presentationThis is to inform the community of all Orthopaedic and Hand Surgeons around the world who are interested in Total Wrist Arthroplasty (TWA) about the official decision by the European and German Branches (Winterthur, Switzerland and Freiburg i. Breisgau, Germany) of the company for distribution (Zimmer Biomet Holdings Inc., Warsaw, Indiana/USA) for the Maestro TM Wrist Reconstructive System (WRS, insertion of the carpal plate with variable or fixed locking screws) (Figure 1A-C). Recently, the company informed the author on February 26., 2018 that they have definitively withdrawn the Maestro TM WRS from the marketplace here in Germany, and this decision will be extended in 2018 for all other countries worldwide if the CE certification is finished in these countries in 2018 as well. The company officially wrote that the cause for its withdrawal is that as follows: The Maestro TM WRS is approved only for its cemented use by the US Food and Drug Administration (FDA) and there are no publications in the literature worldwide on favorable results with its cemented use, and so, it cannot be guaranteed the surveillance of this implant by the company if it inserted in a non-cemented manner (i.e. "off-label" use).

Wrist arthroplasty, good alternative for rheumatoid wrist: Case report with literature review

“…10 of them had contralateral arthrodesis around the wrist (5 total and 5 radioscapholunate). All of them preferred WA hand [3]. Those results are encouraging, especially compared to the results of Radmer et al [10] from 2003.…”

“…However, both decreases in pain with some preserved range of motion improve patients' quality of life [2,7]. The risk of failure is reported as similar or higher to wrist fusion [3]. It stresses the importance of proper patient selection for that procedure [2].…”

“…The wrist must be stable and balanced with tendon stabilizers. The course of the disease also must be stable and well-controlled [3]. The RA wrist should resemble a pure arthritis wrist [1,4].…”

"Off label" use of the ReMotionTM total wrist for treatment of advanced stage of post-traumatic pancarpal wrist osteoarthritis: Report of two cases and review of literature

“…This advantage with the Maestro was based on design-related features: (1) it had a concave to distally curved carpal component design (i.e. tapered), and (2) the three available sizes of intercalated carpal heads allowed more better restoration of resection-related carpal height than the ReMotion with it two sizes only [18][19][20]28].…”

“…Noted that mid-to long-term outcomes of primary TWF revealed a complication rate ranging from 33 to 60.5% associated with a required re-operation rate ranging from 19 to 63% with a reported predominance in females suffered from inflammatory disease, respectively [14][15][16][17]. From all 3rd generation TWAs the Maestro was superior both in terms of longevity and functional outcome over the other types, however, this implant was withdrawn from the marketplace because it was no longer profitable for the company, and now surgeons have explanation misery to their patients [18][19][20][21][22].…”