FDA Adverse Event
Injury
Summary report: N
NEXGEN STEMMED NONAUGMENTABLE TIBIA
MDR report key: 1884577
·
Received October 19, 2010
Report
- Report Number
- 2648920-2010-00054
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- September 6, 2010
- Report Date
- September 23, 2010
- Manufacturer
- ZIMMER
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON PERFORMED AN ADDITIONAL SURGERY TO REMOVE A FOREIGN BODY INITIALLY ASSUMED TO BE A FRAGMENT OF CEMENT. UPON REMOVAL, THE ITEM PROVED TO BE A SMALL FRAGMENT OF METAL. AFTER REVIEWING THE POST-OP FILMS ON HIGHER MAGNIFICATION, IT IS BELIEVED THAT THE FRAGMENT ORIGINATED FROM THE TIBIAL TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN STEMMED NONAUGMENTABLE TIBIA | KNEE PROSTHESIS | JWH | ZIMMER | 60430203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |