InjuryMBB
SIMPLEX HV
Received Dec 8, 2025 · Event occurred Nov 10, 2025
Report 9615014-2025-00008 · MDR key 23741362
Device
Generic name
Simplex Hv With Gentamicin
Manufacturer
Osartis GmbhModel number
6195-1-001Catalog number
6195-1-010
Lot number
711BA850CY
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
76 YR · Male
- Unspecified Infection
- Implant Pain
- Unspecified Infection
- Implant Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN I&D WITH WASHOUT AND POLY SWAP OF A 4X9 CS INSERT WAS PERFORMED.
Remedial action
- Notification