inforMED
InjuryKWS

TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4C 137.5DG 78MM

Received Jul 15, 2026 · Event occurred Jun 16, 2026

Report 3000931034-2026-00574 · MDR key 25829141

Device

Generic name

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Manufacturer

Tornier S.a.s.

Catalog number

DWF604C

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Female

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Description of Event or Problem

AS REPORTED; "REVISION OF HEMI ARTHROPLASTY. THIS WAS A SECOND STAGE PROCEDURE. THE FIRST REVISION WAS BACK IN (B)(6) 2025. AFTER THIS CASE A HEMI WAS LEFT IN SITU. IN THIS SECOND REVISION THE IMPLANTS WERE ALL REMOVED AND ANOTHER COMPANIES PROSTHESIS WAS IMPLANTED."