InjuryMBB
SIMPLEX HV
Received Jun 26, 2026 · Event occurred Aug 18, 2025
Report 9615014-2026-00004 · MDR key 25634353
Device
Generic name
Simplex Hv With Genta
Manufacturer
Osartis GmbhModel number
6195-1-001Catalog number
6195-1-010
Lot number
317BB844EE
Product problems
- Patient Device Interaction Problem
Patient
80 YR · Female
- Loss of Range of Motion
- Arthralgia
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. IN LATE (B)(6), THE PATIENT ALLEGEDLY DEVELOPED INCREASING PAIN AND FUNCTIONAL IMPAIRMENT. THE PATIENT WAS REVISED ON (B)(6) 2025 DUE TO THE ALLEGED "FAILURE OF THE POLYETHYLENE LINER, WHICH PERMITTED ABNORMAL MOVEMENT AND MISALIGNMENT OF THE FEMORAL AND TIBIAL COMPONENTS".
Remedial action
- Notification