StageOne (cement speyser)

2020: The statement of the producer for the rejected devices

In the middle of March, 2020 the Zimmer Biomet company warned users about the undesirable phenomena which can arise when using disposable forms for cement speyser of StageOne and StageOne Select because of insufficient cleaning and inadequate monitoring.

Orthopedic disposable silicone molds of Zimmer Biomet are intended for filling with bone cement which allows to create time laying (speyser) for the people undergoing two-stage testing before implantation because of a possible infection. A cement speyser usually leave for the term of less than six months with a partial load until the second phase of audit allowing to implant a normal prosthesis is completed.

Zimmer Biomet warned about the rejected time prostheses of a knee joint after release of 230 thousand devices

According to the notification, a number of forms for cement speyser underwent inadequate process of cleaning, and inadequate monitoring of parameters of cleaning was in certain cases noted. The company sold more than 230,000 devices and already received five complaints to the undesirable phenomena which can be connected with this problem. Among the heaviest - adverse local reaction of fabric and pain in an installation site of a cement speyser and also the expressed system reaction to allergen or toxin.

Zimmer Biomet asks not to use these devices as a precautionary measure. Users of implants are recommended to place all potentially rejected devices which are present at their organization in a quarantine and also to warn the sales representative of Zimmer Biomet that these devices could be utilized. The company did not offer specific instructions for monitoring of patients in addition to the existing diagram of observation. The potential undesirable phenomena can arise within one year after the beginning of two-stage assessment.^[1]

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