FDA Adverse Event
Injury
Summary report: N
DEPUY ATTUNE, MOBILE BEARING - TOTAL KNEE REPLACEMENT
MDR report key: 8286350
·
Received January 28, 2019
Report
- Report Number
- MW5083439
- Event Type
- Injury
- Date Received
- January 28, 2019
- Date of Event
- April 6, 2016
- Report Date
- January 25, 2019
- Manufacturer
- DEPUY SYNTHES, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
SEPSIS 5 WEEKS AFTER TKA; LOOSENING- TIBIA AND PATELLA, REVISION NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74999 | DEPUY ATTUNE, MOBILE BEARING - TOTAL KNEE REPLACEMENT | PROSTHESIS, KNEE,PATELLO FEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, METAL BE | JWH | DEPUY SYNTHES, INC. | 8173831;8245920;8039458;805907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |