FDA Adverse Event
Injury
Summary report: N
PLUS
MDR report key: 1012574
·
Received March 12, 2008
Report
- Report Number
- 9612771-2008-00013
- Event Type
- Injury
- Date Received
- March 12, 2008
- Report Date
- March 12, 2008
- Manufacturer
- PLUS ORTHOPEDICS AG
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO RESTRICTED MOVEMENT OF THE ROTATION PEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUS | FEMORAL COMPONENT | KWY | PLUS ORTHOPEDICS AG | NA | 0305.13.2629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |