FDA Adverse Event
Injury
Summary report: N
DURAMER ADVANTIM POST. STAB. TIBIAL INSERT
MDR report key: 822855
·
Received February 28, 2007
Report
- Report Number
- 1043534-2007-00031
- Event Type
- Injury
- Date Received
- February 28, 2007
- Date of Event
- January 26, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KRP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED FROM THE USER FACILITY AND THE SURGEON. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USER FACILITY. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2007-00029, 00030.
Description of Event or Problem · 1
ALLEGEDLY PT'S LEG WAS AMPUTATED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURAMER ADVANTIM POST. STAB. TIBIAL INSERT | KNEE COMPONENT | KRP | WRIGHT MEDICAL TECHNOLOGY, INC. | * | 12235645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R |