Unk Simpliciti implants

Description of Event or Problem

The manufacturer became aware of a literature published by the St. Elizabeth Healthcare Institutional Review Board. The title of this report is ¿"Posterior-approach total shoulder arthroplasty: a case series with a minimum of 2-year outcomes", published on May 13,2021, which is associated with the Stryker T&E - Tornier Simplicity system. The article can be found on https://doi.org/10.1016/j.jse.2021.04.033.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available. It was reported that: "patient complained of weakness following...arthroplasty. Her forward flexion strength appeared to be limited to 90 for 3 months following the procedure, but she could forward flex more fully in the supine position. Electromyography and CT arthrogram were used to assess for the presence of axillary nerve function and the presence or absence of a rotator cuff tear. The electromyography scan showed full activity to the axillary nerve, and the CT arthrogram demonstrated a fully intact rotator cuff. "[She]" regained her strength and had improvement in her ROM by 6 months."

Additional Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature. The article can be found at https://doi.org/10.1016/j.jse.2021.04.033.The reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.