Unk Simpliciti implants
Received Jul 27, 2026 · Event occurred Jan 1, 2022
Report 0001649390-2026-00755 · MDR key 50033595
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
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
The manufacturer became aware of a literature published with title "Early fixation of the humeral component in stemless total shoulder arthroplasty", published on January 1, 2022, which is associated with the Stryker T&E - Tornier Simplicity system. The article can be found on https://doi.org/10.1302/0301-620X.104B1.BJJ-2021-0945.R1.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: "In another patient, a deep venous thrombosis was diagnosed four weeks postoperatively."
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/10.1302/0301-620X.104B1.BJJ-2021-0945.R1.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.