FDA Adverse Event
Injury
Summary report: N
AESCULAP VEGA
MDR report key: 7979384
·
Received October 17, 2018
Report
- Report Number
- MW5080667
- Event Type
- Injury
- Date Received
- October 17, 2018
- Date of Event
- August 10, 2018
- Manufacturer
- B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC
- Product Code
- JWH
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLETE TIBIAL LOOSENING AND DEBONDING WITH FEMORAL FAILURE. ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813738 | AESCULAP VEGA | TOTAL KNEE REPLACEMENT | JWH | B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |