QUICKVALVE

Description of Event or Problem

WHEN GETTING OUT OF THE CAR THE PATIENT LOST THEIR PROSTHESIS (TT). HE LOST HIS BALANCE AND WANTED TO USE THE CONTRALATERAL LEG TO CATCH HIMSELF. THIS RESULTED IN AN INJURY TO HIS THIGH. AN OPERATION WAS NECESSARY. THIS EVENT HAPPENED IN GERMANY.

Additional Manufacturer Narrative

THIS INCIDENT HAPPENED IN GERMANY BUT THE VALVE 21Y2 IS ALSO SOLD IN THE US. THE ENTIRE TRANSTIBIAL PROSTHESIS INCLUDING LINER (SKEO SEALING TT LINER 6Y112=265X80) WAS SENT IN. THE LINER SHOWS NO DEFECTS AND IS IN PERFECT CONDITION. THE 21Y2=M10 QUICKVALVE COMPLAINED ABOUT SHOWS NO DEFECTS EITHER. AN 80 % VACUUM WAS APPLIED TO THE VALVE FOR 3 MINUTES. NO LEAKS WERE FOUND. VENTILATION TOOK PLACE ONLY AFTER THE INTENDED OPENING OF THE VALVE. THE VALVE IS POSITIONED IN THE SOCKET AT A POSITION BELOW THE SEALING LIP OF THE LINER. THE SEAL OF THE LOWER VALVE PART IS CLEAN. THE PRODUCTS REQUIRED TO SECURE THE PROSTHETIC SOCKET (SKEO SEALING TT LINER AND QUICKVALVE) ARE IN A VERY GOOD AND FUNCTIONAL CONDITION. SIMPLE, UNINTENTIONAL DETACHING OF THE PROSTHETIC SOCKET IS NOT POSSIBLE IF USED PROPERLY. BASED ON THIS INVESTIGATION, WE CAN RULE OUT THE PRODUCT AS THE CAUSE OF THE FALL.

Additional Manufacturer Narrative

THIS INCIDENT HAPPENED IN GERMANY BUT THE VALVE 21Y2 IS ALSO SOLD IN THE US. THE COMPLAINT DESCRIPTION IS INCOMPLETE AND THE PRODUCT HAS NOT BEEN SEND TO OTTOBOCK. MORE INFORMATION AND THE PRODUCT HAVE BEEN REQUESTED, GOOD FAITH EFFORT IS RUNNING. WE WILL SEND A FOLLOW UP REPORT ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

WHEN GETTING OUT OF THE CAR THE PATIENT LOST THEIR PROSTHESIS (TT). HE LOST HIS BALANCE AND WANTED TO USE THE CONTRALATERAL LEG TO CATCH HIMSELF. THIS RESULTED IN AN INJURY TO HIS THIGH. AN OPERATION WAS NECESSARY. THIS EVENT HAPPENED IN GERMANY.