Unk Simpliciti implants
Received Jul 27, 2026 · Event occurred May 30, 2021
Report 0001649390-2026-00750 · MDR key 50033563
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
Unk_WTB
Lot number
Unknown
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
The manufacturer became aware of a literature published by the Duke University Medical Center. The title of this report is "Demographic and radiographic predictors of patient reported outcomes and revision surgery after stemless total shoulder arthroplasty", published on May 30,2021, which is associated with the Stryker T&E - Tornier Simplicity system. The article can be found on https://doi.org/10.1053/j.sart.2021.04.012.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: "one had a prosthetic joint infection and underwent irrigation and debridement and humeral head exchange".
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.2021.04.012.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.