PURIST
Received Feb 9, 2024 · Event occurred Dec 4, 2023
Report 3009611746-2024-00001 · MDR key 18678124
Device
Generic name
Table And Attachments - Operating Room- Leg Positioning System
Manufacturer
Jossi AgCatalog number
6813100
Lot number
6813100.00093
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Female
- Limb Fracture
- Limb Fracture
Narrative
Additional Manufacturer Narrative
MANUFACTURE INVESTIGATED THE TRAINING OF THE USERS, STATE OF FUNCTIONING OF THE DEVICE, STATE OF HEALTH OF PATIENT INCLUDING BONE QUALITY, AND CONFIRMED SURGEON FOLLOWED IFU AND SURGICAL PROCEDURE. NO FAILURES OR DEVIATIONS HAVE BEEN FOUND. THE PATIENT'S BONE QUALITY IS UNKNOWN AND IS THE MOST LIKELY CAUSE OF THE FRACTURE.
Description of Event or Problem
ON THE DAY AFTER HIP SURGERY DONE WITH USING PURIST LEG POSITIONING SYSTEM, PATIENT COMPLAINED OF SWELLING IN THE ANKLE AND A BIT OF DISCOMFORT. PATIENT LET THE SURGEON KNOW ABOUT 10 DAYS AFTER SURGERY. SURGEON ORDERED X-RAY WHICH SHOWED A DISPLACED FRACTURE OF THE ANKLE (SPECIFIC BONE NOT PROVIDED). PATIENT PUT IN A STIRRUP BRACE BUT NO SURGERY REQUIRED. PATIENT HAS NOT BEEN TO A FOLLOW UP APPOINTMENT.