FDA Adverse Event
Injury
Summary report: N
NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR3-12
MDR report key: 4209724
·
Received October 22, 2014
Report
- Report Number
- 3005751028-2014-00084
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- April 24, 2012
- Report Date
- October 17, 2014
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- JWH
- PMA / PMN Number
- K012866
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE IMPLANT'S MANUFACTURING RECORD INDICATES THA TIT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.
Description of Event or Problem · 1
IT IS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010 THAT INCLUDED THE TM MONOBLOCK TIBIA. PATIENT EXPERIENCED PAIN, AND WAS REVISED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672337 | NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR3-12 | TM MONOBLOCK TIBIA | JWH | ZIMMER TRABECULAR METAL TECHNOLOGY | 61239764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |