ANKLE PROSTHESIS
Received Oct 10, 1995
Report MW4000871 · MDR key 27446
Device
Generic name
Prosthesis
Manufacturer
Maramed Orthopedic SystemsProduct problems
- Break
Patient
*
- Fall
Narrative
Description of Event or Problem
TWICE IN THE LAST TWO YEARS RPTR HAS NARROWLY MISSED SERIOUS INJURY AS A RESULT OF A FALL CAUSED BY BREAKAGE OF AN ANKLE COMPONENT IN HIS RIGHT LEG PROSTHESIS. RPTR CAN ONLY SURMISE THAT THE ANKLE COMPONENT WAS EITHER IMPROPERLY MANUFACTURED OR MADE FROM INFERIOR MATERIALS.