FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) TOTAL HEAD W/BFH
MDR report key: 1930761
·
Received December 16, 2010
Report
- Report Number
- 1043534-2010-00520
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- September 16, 2009
- Report Date
- November 18, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K021349
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO DEVICE FAILURE. COMPLAINT HISTORY REVIEWED AND ANALYSIS SHOWS NO TRENDS FOR THE ITEM OR LOT NUMBER. DEVICE HISTORY RECORD REVIEWED AND INDICATES THE PRODUCT MET SPECIFICATIONS WHEN MANUFACTURED. PRODUCT NOT RETURNED. WITH THE INFORMATION PROVIDED, THIS PRODUCT DID NOT CONTRIBUTE TO THE EVENT.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00519, 00521, 00522. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
ALLEGEDLY PATIENT FELT PAIN AND UNCOMFORTABLENESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) TOTAL HEAD W/BFH | HIP COMPONENT | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 068602440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |