TORNIER HRS ASSEMBLY SCREW 0MM
Received Jul 17, 2026 · Event occurred Jun 22, 2026
Report 0001649390-2026-00726 · MDR key 25861987
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Tornier IncCatalog number
ARS655101
Lot number
AZ1923118138
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
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.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.