InjuryKYJ

DJO SURGICAL

Received Jun 22, 2026 · Event occurred Jun 1, 2026

Report 1644408-2026-01208 · MDR key 25586574

Device

Generic name

Silicone Ii Mcp Implant Size 30 (sterile Packed)

Manufacturer

Encore Medical L.p.

Catalog number

MCP-30

Lot number

K51808

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

63 YR · Female

Unspecified Infection

Narrative

Additional Manufacturer Narrative

THE AGENT REPORTED: REVISION SURGERY DUE TO INFECTION. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2023-00529; (B)(4) INFECTION, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION.