FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 1140993
·
Received August 29, 2008
Report
- Report Number
- 1020279-2008-00240
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 29, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- KWB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE WHICH MAY HAVE OCCURRED DUE TO THE PATIENT FALLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLECTION | LINER | KWB | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| O |