REMEDY STEMMED KNEE
Received Feb 17, 2021 · Event occurred Jan 14, 2021
Report 3010537287-2021-00002 · MDR key 11340270
Device
Generic name
Stemmed Tibial Component Lg
Manufacturer
Osteoremedies, LlcModel number
RSKTLGCatalog number
RSKTLG
Lot number
OR01124
Product problems
- Break
- Break
Patient
58 YR
- Failure of Implant
- Limited Mobility Of The Implanted Joint
- Failure of Implant
- Limited Mobility Of The Implanted Joint
Narrative
Additional Manufacturer Narrative
PER THE DEVICE LABELING, THE REMEDY® STEMMED KNEE SPACER MAY BE COMPROMISED IN AN OVERWEIGHT OR OBESE PATIENT AND/OR ONE WHO DOES NOT LIMIT THE AMOUNT OF ACTIVITY AND WEIGHT PLACED ON THE KNEE. THE PATIENT IS OBESE AND REPORTED WALKING ON THE DEVICE WITH FULL WEIGHT BEARING.
Description of Event or Problem
ONE MONTH POST-OPERATIVE THE PATIENT WAS WALKING FULL WEIGHT BEARING AND FRACTURED THE TIBIAL KNEE COMPONENT. THE SURGEON REVISED THE KNEE TO REMOVE THE BROKEN SPACER AND REPLACE IT WITH A METAL TIBIAL AND FEMUR STATIC SPACER.