MalfunctionKWS
UNKNOWN FLEX POLY
Received Jul 6, 2026 · Event occurred May 21, 2026
Report 3000931034-2026-00563 · MDR key 25726213
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
UNK_WTM
Lot number
UNKNOWN
Product problems
- Naturally Worn
Patient
NA · Unknown
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND, IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
A PLANNED REVISION SURGERY WAS PERFORMED BY THE SURGEON USING THE BLUEPRINT PLANNING FEATURE. DURING THE PROCEDURE, A FLEX IMPLANT WAS REVISED DUE TO EARLY LOSS OF BASEPLATE FIXATION, RESULTING IN ABNORMAL POLYETHYLENE WEAR AND PERSISTENT PAIN.