FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1040179
·
Received May 8, 2008
Report
- Report Number
- 1020279-2008-00146
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 24, 2007
- Report Date
- May 8, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE IMPLANTATION OF A LEFT TIBIAL BASE INTO THE PT'S RIGHT KNEE. THE PRODUCT WAS LABELED APPROPRIATELY; THEREFORE, THIS IS CONSIDERED TO BE A SURGEON ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | TIBIAL BASE | HSH | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |