FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL HEAD W/BFH
MDR report key: 2990341
·
Received March 5, 2013
Report
- Report Number
- 1043534-2013-00437
- Event Type
- Injury
- Date Received
- March 5, 2013
- Report Date
- February 21, 2013
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K021349
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01420, 1043534-2013-00438, 00439.THIS EVENT OCCURRED IN THE (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY RIGHT HIP WAS REVISED DUE TO MOM COMPLICATIONS. ORIG. SURG. (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93283 | CONSERVE(R) TOTAL HEAD W/BFH | HIP COMPONENT, CODE:KWA | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 0401084481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |