FDA Adverse Event
Injury
Summary report: N
POROUS NEXGEN TM PATELLA, 35MM DIA.
MDR report key: 3203707
·
Received June 24, 2013
Report
- Report Number
- 3005751028-2013-00059
- Event Type
- Injury
- Date Received
- June 24, 2013
- Date of Event
- September 5, 2012
- Report Date
- June 24, 2013
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- JWH
- PMA / PMN Number
- K011904
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 COUNSEL THAT THE PT RECEIVED A RIGHT TKA ON (B)(6) 2010, FOR CORRECTION OF SEVERE ARTHRITIS. ON (B)(6) 2012, THE PT WAS REVISED FOR ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286440 | POROUS NEXGEN TM PATELLA, 35MM DIA. | TM PATELLA | JWH | ZIMMER TRABECULAR METAL TECHNOLOGY | 61554526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |