UNKNOWN POLY
Received Jul 10, 2026 · Event occurred May 25, 2026
Report 0001649390-2026-00714 · MDR key 25782759
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
- Fall
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: "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, THESE WERE TORNIER IMPLANTS. 2. DID A STRYKER DEVICE CAUSE OR CONTRIBUTE TO THE NEED FOR REVISION (IE, BREAKAGE, PRE-MATURE WEAR, OTHER)? PATIENT FELL AND BASEPLATE RIPPED OUT BUT THERE WAS ALSO EXCESSIVE WEAR ON THE NON VITAMIN E POLY. 3. WAS THERE AN ISSUE DURING THE PRIMARY PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE NEED FOR A REVISION? NO ISSUE IN THE PRIMARY REVERSE. 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? NO PATIENT FELL AND RIPPED IT OUT."