MalfunctionHSH
NKII DURASUL CONGRUENT TIBIAL INSERT
Received Dec 1, 2010
Report 1822565-2010-01248 · MDR key 1916255
Device
Product problems
- Device remains implanted
- Unknown (for use when the device problem is not known)
Patient
59 YR
- Ambulation or Postural Difficulties
Narrative
Additional Manufacturer Narrative
INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT IS REPORTED THAT THE PT IS HAVING DIFFICULTIES STEPPING DOWN AND HAS FALLEN APPROXIMATELY 7 TIMES THIS YEAR.