FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT
MDR report key: 1934730
·
Received December 21, 2010
Report
- Report Number
- 1043534-2010-00610
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- May 1, 2008
- Report Date
- November 18, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JWH
- PMA / PMN Number
- K972626
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THE PATIENT AND USER FACILITY INFORMATION WERE NOT PROVIDED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00611, 00612, 00613. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY PER NJR OF (B)(6), THIS PRODUCT WAS REMOVED DUE TO WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT | KNEE COMPONENT | JWH | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| R |