FDA Adverse Event
Injury
Summary report: N
KLASSIC KNEE TIBIAL SET SCREW FOR PRIMARY OR REVISION
MDR report key: 11437443
·
Received March 8, 2021
Report
- Report Number
- 3008544874-2021-00002
- Event Type
- Injury
- Date Received
- March 8, 2021
- Date of Event
- December 7, 2021
- Report Date
- March 2, 2021
- Manufacturer
- TOTAL JOINT ORTHOPEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K112906
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
TIBIAL SET SCREW IS USED AS ONE OF THE MECHANISMS TO LOCK THE TIBIAL INSERT INTO THE TIBIAL BASEPLATE, IT WAS REPORTED THAT THE SCREW WAS LOOSE IN THE JOINT SPACE. SURGEON PERFORMED REVISION SURGERY TO REMOVE THE SCREW AND IMPLANT A NEW SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332284 | KLASSIC KNEE TIBIAL SET SCREW FOR PRIMARY OR REVISION | TIBIAL SET SCREW | JWH | TOTAL JOINT ORTHOPEDICS, INC. | 143728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |