TORNIER HRS PROXIMAL BODY DIA 9
Received Jul 15, 2026 · Event occurred Jun 22, 2026
Report 0001649390-2026-00717 · MDR key 25826739
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Tornier IncCatalog number
ARS741701
Lot number
AZ2922130020
Product problems
- Inadequacy of Device Shape and/or Size
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE INVOLVING A REVIVE STEM. DURING THE REVISION, THE PROXIMAL BODY, ASSEMBLY SCREW, LOCKING CAP, POLYETHYLENE INSERT, AND ASCEND FLEX TRAY WERE REMOVED. THE DISTAL STEM REMAINED IN SITU. THE PROXIMAL SECTION WAS REPLACED WITH NEW COMPONENTS, INCLUDING UPSIZING THE PROXIMAL BODY TO A SIZE 11.