inforMED
InjuryKWI

EVOLVE STEM 8.5MM

Received May 19, 2026 · Event occurred Apr 21, 2026

Report 3010667733-2026-00504 · MDR key 25217214

Device

Generic name

Prosthesis, Elbow, Hemi-, Radial, Polymer

Catalog number

496S085

Lot number

1801811

Product problems

  • Detachment of Device or Device Component

Patient

NA · Male

  • Insufficient Information

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 CASE IN WHICH EVOLVE WAS IMPLANTED ON APRIL 7. POSTOPERATIVE FOLLOW-UP X-RAYS CONFIRMED SEPARATION BETWEEN THE STEM AND THE HEAD. REVISION SURGERY IS SCHEDULED FOR APRIL 28."