HEIGHT ADJUSTABLE PYLON
Received Oct 17, 2023
Report 3003764610-2023-00016 · MDR key 17950150
Product problems
- Material Separation
- Insufficient Device Problem Information
- Material Separation
- Insufficient Device Problem Information
Patient
Unknown
- Joint Dislocation
- Subluxation
- Joint Dislocation
- Subluxation
Narrative
Description of Event or Problem
THE PATIENT WAS WALKING ON GRASS WHEN THE ADAPTER GAVE WAY DUE TO A CRACK. THE PATIENT FELL AND DISLOCATED HIS PATELLA.
Additional Manufacturer Narrative
ANALYSIS OF THE PRODUCT SHOWED CLEAR SIGNS OF CORROSION THAT LIKELY LED TO CRACKS FORMING NEAR THE SET SCREWS DUE TO STRESS CORROSION CRACKING. SET SCREWS WERE CHANGED FROM THE WEATHERPROOF SCREWS SUPPLIED BY ÖSSUR TO WATERPROOF WHICH MAY INDICATE THAT COMPONENT IS NOT TOLERATING THE USE ENVIRONMENT. PATIENT IS 82 KG AND THE ACTIVITY LEVEL OF THE PATIENT IS HIGH. PATIENT SHOULD NOT USE ALUMINUM PRODUCT IF ACTIVITY LEVEL IS HIGH. THE IFU STATES THAT THE DEVICE IS WEATHERPROOF AND THEREFORE CANNOT BE USED IN A CORROSIVE ENVIRONMENT, BUT CLEAR INDICATION IS THAT THE PRODUCT WAS EXPOSED TO A CORROSIVE AGENT AS ANALYSIS OF THE DEVICE PROVES.
Description of Event or Problem
THE PATIENT WAS WALKING ON GRASS WHEN THE ADAPTER GAVE WAY DUE TO A CRACK. THE PATIENT FELL AND DISLOCATED HIS PATELLA.