FDA Adverse Event
Injury
Summary report: N
DURAMER(R) ADVANTIM(R) TIBIAL INSERT
MDR report key: 807845
·
Received January 19, 2007
Report
- Report Number
- 1043534-2007-00012
- Event Type
- Injury
- Date Received
- January 19, 2007
- Date of Event
- December 18, 2006
- Report Date
- January 7, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KRP
- PMA / PMN Number
- k893252
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND THE SURGEON. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY SURGEON OPERATED TO INSERT PATELLA BUTTON AND WHILE THERE CHANGED INSERT. INSERT LOOKED GOOD WITH NO OBVIOUS WEAR VISIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURAMER(R) ADVANTIM(R) TIBIAL INSERT | JWH | KRP | WRIGHT MEDICAL TECHNOLOGY, INC. | * | 01461551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R |