DONJOY
Received Jan 14, 2025 · Event occurred Dec 27, 2024
Report 9616086-2025-00001 · MDR key 21154542
Device
Product problems
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "THERE IS A BROKEN HINGE THAT KEEPS THE KNEE LOCKED AT ZERO. THE LOCK WON'T STAY LOCKED AT ZERO, BUT IT WILL LOCK AT OTHER ANGLES. I THINK THE GEARS AT THE ZERO MARK ARE BROKEN SO IT WON'T HOLD THE BRACE IN THE LOCKED POSITION. NO INJURY CAUSED BY THIS MALFUNCTION". THE BRACE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS DAMAGED COMPONENT BASED ON OTHER DEVICES THAT HAVE BEEN EVALUATED. THE DEVICES LOCK BUTTON FAILED DURING MANUFACTURING TESTING CONFIRMED TO BE THE SAME MALFUNCTION FOUND IN REPORT NUMBER 9616086-2023-00007. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT "THERE IS A BROKEN HINGE THAT KEEPS THE KNEE LOCKED AT ZERO. THE LOCK WON'T STAY LOCKED AT ZERO, BUT IT WILL LOCK AT OTHER ANGLES. I THINK THE GEARS AT THE ZERO MARK ARE BROKEN SO IT WON'T HOLD THE BRACE IN THE LOCKED POSITION."