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
Manufacturer
Waldemar Link Gmbh & Co. KgModel number
15-8022/11ULot 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.