FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 1618575
·
Received February 26, 2010
Report
- Report Number
- 9613369-2010-00011
- Event Type
- Injury
- Date Received
- February 26, 2010
- Date of Event
- January 29, 2010
- Report Date
- February 25, 2010
- Manufacturer
- SMITH & NEPHEW, INC. AG ORTHOPAEDIC DIVISION
- Product Code
- EKD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED BECAUSE THE SAWBLADES WOULD NOT FIT THROUGH THE CUTTING BLOCKS CORRECTLY. THE SURGEON ELECTED TO CONTINUE WITH THE SURGERY, AND ONCE THE SURGICAL PROCEDURE WAS COMPLETED, THE UNICONDYLAR KNEE COMPONENTS DID NOT TRACK CORRECTLY. AT THAT TIME THE SURGEON ELECTED TO CHANGE FROM THE UNICONDYLAR KNEE TO A TOTAL KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | SAWBLADE/EKD | EKD | SMITH & NEPHEW, INC. AG ORTHOPAEDIC DIVISION | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization |