FDA Adverse Event
Malfunction
Summary report: N
NEXGEN STEMMED TIBIAL PLATE
MDR report key: 3142790
·
Received May 24, 2013
Report
- Report Number
- 1822565-2013-00867
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 24, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 DOCTOR ATTEMPTED TO USE A SIZE 4 TIBIA. THE TIBIA WOULD NOT LOCK INTO A SIZE 11 FEMORAL. THE SURGERY WAS COMPLETED WITH A SIZE 3 TIBIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230908 | NEXGEN STEMMED TIBIAL PLATE | JWH | ZIMMER, INC. | 62283417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |