FDA Adverse Event
Injury
Summary report: N
ADVANCE DOUBLE HIGH TIBIAL INSERT
MDR report key: 1021979
·
Received March 28, 2008
Report
- Report Number
- 1043534-2008-00047
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- February 27, 2008
- Report Date
- March 10, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE. A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00048, 00049, 00050.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO SEVERE HYPEREXTENSION OF THE LEFT KNEE WITH SIGNIFICANT STRETCHING OF THE POSTERIOR CAPSULE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE DOUBLE HIGH TIBIAL INSERT | HSH | WRIGHT MEDICAL TECHNOLOGY, INC. | 035206320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |