TOTAL KNEE 2100
Received Oct 9, 2020
Report 0001836248-2020-00003 · MDR key 10655463
Device
Product problems
- Deformation Due to Compressive Stress
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
USER FELL WHEN USING HIS PROSTHETIC KNEE. USER EXPERIENCED SERIOUS INJURIES AS HE INJURED HIS HIP AND NEEDED TO UNDERGO A SURGERY.
Additional Manufacturer Narrative
INITIALLY THE MANUFACTURER WAS INFORMED THAT THE PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT MIGHT HAVE FALLEN BUT NO INFORMATION WERE GIVEN REGARDING ANY INJURIES. AFTER SEVERAL ATTEMPTS CONTACTING THE CLINIC THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD BEEN INJURED AND HAD TO BE HOSPITALIZED.
Additional Manufacturer Narrative
INITIALLY THE MANUFACTURER WAS INFORMED THAT THE PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT MIGHT HAVE FALLEN BUT NO INFORMATION WERE GIVEN REGARDING ANY INJURIES. AFTER SEVERAL ATTEMPTS CONTACTING THE CLINIC THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD BEEN INJURED AND HAD TO BE HOSPITALIZED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.
Description of Event or Problem
PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT WAS HOSPITALIZED.