FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL HEAD W/BFH
MDR report key: 6059505
·
Received October 26, 2016
Report
- Report Number
- 3010536692-2016-01328
- Event Type
- Injury
- Date Received
- October 26, 2016
- Date of Event
- September 26, 2016
- Report Date
- September 27, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- PMA / PMN Number
- K021349
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALLEGEDLY THE CUP SLIPPED OUT OF SOCKET (RIGHT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707921 | CONSERVE(R) TOTAL HEAD W/BFH | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | 077458448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |