Unk Simpliciti implants
Received Jul 28, 2026 · Event occurred Jan 1, 2024
Report 0001649390-2026-00766 · MDR key 50052887
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
Unk_WTB
Lot number
Unknown
Product problems
- Osseointegration Problem
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the ankle joint replacement. The report details analysis provided for revision procedures.During the review of the report, it was identified that 7 patients required revision surgery due to loosening, which was not previously reported to the manufacturer.This is patient 4 of 7.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation, and no other additional information was received from the National Joint Registry.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.Please note, that reports received from the National Joint Registry are not published reports and therefore web link is not available.