inforMED
InjuryMBB

SIMPLEX HV

Received Oct 22, 2025 · Event occurred Jun 19, 2025

Report 9615014-2025-00007 · MDR key 23356123

Device

Generic name

Simplex Hv With Gentamicin

Manufacturer

Osartis Gmbh

Model number

6195-1-001

Catalog number

6195-1-010

Lot number

014BA485BC

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

58 YR · Male

  • Arthritis
  • Arthralgia
  • Implant Pain
  • Joint effusion
  • Arthritis
  • Arthralgia
  • Implant Pain
  • Joint effusion

Narrative

Description of Event or Problem

PATIENT REPORTED; HE HAD A PARTIAL KNEE REPLACEMENT WITH STRYKER ORTHOPEDICS KNEE AND HAVING PROBLEMS WITH IT. SWELLING WITH FLUIDS AND PAIN. FLUIDS WERE DRAINED BUT RETURNED. PATIENT HAS RECEIVED SHOTS OF CORTISONE.