inforMED
InjuryHRZ

ROTATING HINGED TOTAL KNEE PROSTHESIS

Received Mar 11, 2019 · Event occurred Sep 16, 2015

Report 3006721341-2019-00003 · MDR key 8410051

Device

Generic name

Rotating Hinged Total Knee Prosthesis

Model number

15-8022/11U

Lot number

020413/0597

Product problems

  • Fracture
  • Fracture

Patient

65 YR

  • Failure of Implant
  • Failure of Implant

Narrative

Description of Event or Problem

PER CONVERSATION WITH THE REPRESENTATIVE IN THE ROOM, PATIENT PRESENTED TO SURGEON WITH A DISLOCATED ENDO KNEE. SHE DIDN'T KNOW HOW IT HAPPENED AND IT HAD BEEN THAT WAY "FOR A WHILE". DR. WAS ABLE TO EXPOSE THE KNEE, REMOVE THE OLD TIBIAL PLATEAU, REDUCE THE KNEE AND INSERT A NEW TIBIAL PLATEAU. COULD NOT TELL THE MODE OF DISLOCATION. THE FEMUR HAD PULLED OFF THE TIBIA, BUT THE PLASTIC INSERT WAS STILL ON THE TIBIA. IT LOOKED LIKE THE FEMALE BUSHING OF THE FEMUR HAD WORN THROUGH THE TIBIAL PLATEAU PLASTIC. SURGEON WAS HAPPY WITH THE RESULT. NOTE: THIS IS NOT A NEW EVENT. THE MANUFACTURER NOTIFIED FDA UNDER MDR # 3004371426-2015-00004.