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, LlcModel number
125461Catalog 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.