OSSUR ICELOCK CLUTCH 4H 214

Description of Event or Problem

DEVICE ASSEMBLY - LOWER LIMB EXTERNAL PROSTHETIC LEG. THE PIN ATTACHMENT ON THE SOCKET LINER DISENGAGED WITH THE LOCKING MECHANISM ON THE PROSTHETIC LIMB. THE FOOT SECTION OF THE PROSTHESIS SUBSEQUENTLY BECAME DISCONNECTED FROM THE REMAINDER OF THE PROSTHESIS STILL ON THE PT'S LEG. THE PT LOST THEIR BALANCE AND FELL ON THEIR RESIDUAL LIMB RESULTING IN A FRACTURED FIBULA. WHEN THIS EVENT WAS ORIGINALLY REPORTED IN 2001, IT WAS INDICATED THAT THE PT REC'D BRUISING AND SWELLING BUT WAS OTHERWISE OK. THE CO DID PURSUE THIS EVENT VIA THE CO'S INJURY INVESTIGATION PROCEDURE, AND BASED ON DATA GATHERED CONCLUDED IT WAS NOT AN MDR EVENT. AFTER SEVERAL WEEKS THE PT BECAME DISSATISFIED WITH THEIR RECOVERY AND SOUGHT A SECOND OPINION. THE SECOND OPINION REVEALED THE FRACTURE. THE MEDICAL ADVICE WAS TO STAY OFF THE RESIDUAL LIMB AND ALLOW IT TO HEAL.