InjuryLGE
TIBIAL COMP KIN HINGE KNEE
Received Oct 8, 2018 · Event occurred Jun 1, 2018
Report 0002249697-2018-03237 · MDR key 7945675
Device
Generic name
Knee Joint Femorotibial Metal/polymer Semi-constrained Cemented Prosthesis.
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
64753933
Lot number
UNK
Product problems
- Fracture
- Fracture
Patient
60 YR
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
ON (B)(6) 2018, THERE WAS NO PROBLEM WHEN VISITING OUTPATIENTS IN THE MORNING. MY KNEE SUDDENLY BECAME UNSTABLE FROM THE AFTERNOON AND WENT TO A NEARBY HOSPITAL. VISITED THE ORIGINAL HOSPITAL AGAIN AFTER OBSERVING ABOUT 3 MONTHS. ON SEPTEMBER 27, 2018, IT WAS CONFIRMED THAT REOPERATION WAS CARRIED OUT AND IT WAS BROKEN.