inforMED
InjuryIQO

FILLAUER MODULAR SHUTTLE LOCK

Received Oct 15, 2004 · Event occurred Sep 15, 2004

Report 1022826-2004-00001 · MDR key 549479

Device

Generic name

Prosthetic Suspension Lock

Manufacturer

Fillauer, Llc

Model number

125461

Catalog number

125461

Lot number

UNK

Product problems

  • Loose
  • Material Separation
  • Noise

Patient

65 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE PT IS A BELOW KNEE AMPUTEE AND WAS WALKING IN THEIR HOME WHEN THEIR PROSTHETIC LIMB CAME LOOSE. THE PROSTHETIST INDICATED THAT THIS LIMB WAS NEW AND HAD BEEN IN USE FOR ONLY 8 DAYS. THE PT BELIEVED THE LOCK RELEASED. THEY WERE ABLE TO STOP AND STEP BACK INTO THE SOCKET AND CONTINUE WALKING. LATER THAT AFTERNOON THEIR WERE IN THE BANK AND THEIR LIMB CAME LOOSE AGAIN. THE PROSTHETIC LIMB FELL OFF AND THEY LANDED ON THEIR RESIDUUM. THEY VISITED THEIR PROSTHETIST THAT DAY. THEIR PROSTHETIST SUGGESTED THEY GO TO THE CLINIC TO BE EXAMINED. THEY CHIPPED THE END OF THEIR TIBIA AND WILL NOT BE WALKING FOR 3-4 WEEKS. THE PT ALSO TOLD THEIR PROSTHETIST THAT THEY HAD OTHER OCCASIONS WHEN THEY PUT THE SOCKET ON THE LOCK WOULD CLICK BUT THE PLUNGER LOCATED ON THE END OF THE LINER WOULD PULL RIGHT BACK OUT OF THE LOCK. THEY WOULD THEN REPOSITION THE LINER AND HAVE NO PROBLEM WITH THE LOCK. THE PT THOUGHT THE CLICKING THAT THEY HEARD MAY HAVE BEEN THE PLUNGER TRYING TO ENTER THE LOCK AT AN ANGLE.