UNKNOWN PERFORM HUMERAL IMPLANTS
Received Jun 24, 2026 · Event occurred May 4, 2026
Report 0001649390-2026-00681 · MDR key 25612742
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier IncCatalog number
UNK_WTB
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A REVISION SURGERY SCHEDULED ON (B)(6) 2026 WHICH WAS PLANNED USING THE BLUEPRINT PLANNING FEATURE (CASE ID: (B)(4)). 1. WAS A STRYKER/TORNIER IMPLANT REVISED OR REMOVED IN THIS CASE? - YES, PERFORM HUMERAL. 2. DID A STRYKER DEVICE CAUSE OR CONTRIBUTE TO THE NEED FOR REVISION (IE, BREAKAGE, PRE-MATURE WEAR, OTHER)? - NO. 3. WAS THERE AN ISSUE DURING THE PRIMARY PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE NEED FOR A REVISION? - OVERSTUFFED HUMERAL HEAD. 4. IS THE REVISION PERFORMED AS A RESULT OF THE NORMAL PROGRESSION OF THE PATIENT¿S CONDITION/DISEASE, RESPECTIVELY IS THE REVISION OTHERWISE USUAL/EXPECTED? - YES.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.