FDA Adverse Event
Injury
Summary report: N
NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6 - 12
MDR report key: 3203724
·
Received June 25, 2013
Report
- Report Number
- 3005751028-2013-00060
- Event Type
- Injury
- Date Received
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- ZIMMER TMT
- Product Code
- JWH
- PMA / PMN Number
- K012866
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFO BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.
Description of Event or Problem · 1
THE PT IS PURSUING A LIABILITY CLAIM ARISING OUT OF THE USE OF THE NEXGEN TM MONOBLOCK TIBIA. IT WAS REPORTED BY THE PT'S COUNSEL THAT THE PT RECEIVED THE IMPLANT ON (B)(6) 2007 AND IS EXPERIENCING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286871 | NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6 - 12 | TM MONOBLOCK TIBIA. | JWH | ZIMMER TMT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |