inforMED
InjuryKWD

CARTIVA IMPLANT

Received Jun 25, 2019 · Event occurred Jun 20, 2019

Report MW5087609 · MDR key 8735162

Device

Generic name

Prosthesis, Toe, Hemi - Phalangeal

Product problems

  • Defective Device

Patient

56 YR

  • Failure of Implant
  • Pain
  • Failure of Implant
  • Pain

Narrative

Description of Event or Problem

HAD CARTIVA IMPLANT ON (B)(6) 2019 FOR BIG TOE ARTHRITIS (HALLUX RIGIDUS). IN ADDITION TO THE PAIN IN MY TOE, I NOW HAVE PAIN ON THE BALL OF MY FOOT. VISITED ORTHOPEDIC SURGEON, YESTERDAY (B)(6) 2019 (6 MONTHS F/U). DR DID AN X-RAY ON BIG TOE AND OCCLUDED THAT THE CARTIVA IMPLANT FAILED. FDA SAFETY REPORT ID# (B)(4).