FDA Adverse Event
Injury
Summary report: N
ADVANCE KNEE SYSTEM
MDR report key: 12314069
·
Received August 12, 2021
Report
- Report Number
- 3010536692-2021-00441
- Event Type
- Injury
- Date Received
- August 12, 2021
- Report Date
- October 20, 2021
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY, A STUDY BY SHI ET AL. REPORTED 2 PATIENTS WHO HAD "SURGERY-RELATED INFECTION" AFTER IMPLANTATION WITH AN ADVANCE MEDIAL-PIVOT KNEE SYSTEM. THE INFECTIONS REPORTEDLY "SUBSIDED AFTER THE SECOND-STAGE REVISION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1211936 | ADVANCE KNEE SYSTEM | KNEE COMPONENT | JWH | MICROPORT ORTHOPEDICS INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |