ASSURE EVO PYR CAT 4 S 28L

Additional Manufacturer Narrative

PATIENT WEIGHT INDICATES HE IS TOO HEAVY FOR THE CATEGORY 4 FOOT AND SHOULD HAVE BEEN PLACED IN A CATEGORY 5 FOOT BY THE HEALTH PROFESSIONAL. THE FEMALE ORTIMEX MATING ADAPTER IS NOT COMPATIBLE WITH THE OSSUR MALE FOOT ADAPTER USED. WE SENT OUT A SAFETY ALERT REMINDING CUSTOMERS TO ONLY USE OSSUR ADAPTERS PER THE IFU.

Description of Event or Problem

BELOW KNEE AMPUTEE PATIENT FELL WHILE WALKING CAUSING BROKEN SHOULDER.