Unk Simpliciti implants

Description of Event or Problem

The manufacturer became aware of a literature published by the University of South Dakota Sanford School of Medicine. The title of this report is "Stemless and stemmed total shoulder arthroplasty: a comparison of short-term clinical and radiographic outcomes", published on Sep. 14, 2022, which is associated with the Stryker T&E - Tornier Simplicity system. The article can be found on https://doi.org/10.1053/j.sart.2022.07.022.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: "Two patients...had a postoperative, traumatic proximal humerus fracture that occurred 4 months and 10 months postoperatively and were successfully treated nonoperatively (ASES at 2-year follow-up ¼ 90 and 100, respectively)."This is patient 2 of 2.

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/10.1053/j.sart.2022.07.022.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.