FDA Adverse Event
Injury
Summary report: N
NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 -
MDR report key: 3143134
·
Received May 29, 2013
Report
- Report Number
- 3005751028-2013-00051
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- December 7, 2011
- Report Date
- May 29, 2013
- Manufacturer
- ZIMMER TMT
- Product Code
- JWH
- PMA / PMN Number
- K020295
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE IMPLANT'S MANUFACTURING RECORD INDICATES THAT IT 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 WAS REPORTED BY THE PT'S LEGAL COUNSEL THAT THE PT RECEIVED A TKA ON (B)(6) 2010. ON (B)(6) 2011, THE PT WAS REVISED DUE TO ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236167 | NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 7 - | TM MONOBLOCK TIBIA | JWH | ZIMMER TMT | 61422853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |