RHEO KNEE XC
Received Jul 17, 2024 · Event occurred Oct 20, 2023
Report 3003764610-2024-00005 · MDR key 19762084
Product problems
- Unintended Movement
- Unintended Movement
Patient
NA · Unknown
- Burn(s)
- Limb Fracture
- Burn(s)
- Limb Fracture
Narrative
Additional Manufacturer Narrative
THE KNEE WAS MANUFACTURED IN APRIL 2016 AND HAD BEEN IN THE FIELD FOR OVER 7 YEARS WHEN THE INJURY OCCURRED. THE USER REPORTED THAT THE DEVICE DID NOT PROVIDE FLEXION RESISTANCE FROM 0-5°. THE LIKELY REASON FOR THE USER EXPERIENCING THE RESISTANCE ISSUE IS THE AGE OF THE ACTUATOR, WHICH WAS INSTALLED ON 2021-01-04 AND WAS THEREFORE ALMOST 3 YEARS OLD. IT IS LIKELY THAT THERE WAS PLAY IN THE UNIT WHICH RESULTED IN THE USER NOT FEELING ANY RESISTANCE IN THE FIRST FEW DEGREES OF FLEXION. THE PROBLEM IS RELATED TO WEAR AND TEAR DURING USE AND THERE IS NO EVIDENCE OF OTHER PROBLEMS OR MANUFACTURING DEFECTS.
Description of Event or Problem
THE USER WAS WALKING THROUGH THE KITCHEN WHEN THE KNEE BUCKLED, IN AN ATTEMPT TO STEADY HIMSELF, THE USER GRABBED THE HANDLE OF A HOT SAUCEPAN ON A STOVE, SPILLING BOILING WATER ON HIS RIGHT ARM AND SUSTAINING A SCALD. HE LANDED ON HIS LEFT HAND, FRACTURING HIS WRIST.