PRO-FLEX LP ALIGN
Received Oct 2, 2025 · Event occurred May 17, 2025
Report 3003764610-2025-00007 · MDR key 23199944
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Hip Fracture
- Hip Fracture
Narrative
Additional Manufacturer Narrative
THE USER SLIPPED ON SPILLED JUICE WHILE LIFTING BOXES. THERE IS NO INDICATION OF PRODUCT, MANUFACTURING OR MATERIAL FAILURE. BASED ON PROVIDED INFORMATION FROM THE HOSPITAL THERE WAS NEVER ANY SUGGESTION THAT THE PROSTHETICS LIMB COMPONENTS WERE TO BLAME FOR THE INCIDENT. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS INJURY IS CONSIDERED NEGLIGIBLE. FURTHER ACTIONS ARE NOT CONSIDERED WARRANTED.
Description of Event or Problem
PATIENT REPORTS FALLING WHILE LIFTING BOXES DURING A HOUSE MOVE. REPORTS THEY SLIPPED ON SOME JUICE SPILLED ON THE FLOOR BY THEIR YOUNG SON. NECK OF FEMUR FRACTURE. ATTENDED A&E AND THEN HAD ORTHO SURGERY TO REPAIR THE FRACTURE. PATIENT ADVISED TO BE NON-WEIGHT BEARING FOR 3 MONTHS.
Description of Event or Problem
PATIENT REPORTS FALLING WHILE LIFTING BOXES DURING A HOUSE MOVE. REPORTS THEY SLIPPED ON SOME JUICE SPILLED ON THE FLOOR BY THEIR YOUNG SON. NECK OF FEMUR FRACTURE. ATTENDED A&E AND THEN HAD ORTHO SURGERY TO REPAIR THE FRACTURE. PATIENT ADVISED TO BE NON-WEIGHT BEARING FOR 3 MONTHS.