FDA Adverse Event
Injury
Summary report: N
ALUMINA HEAD
MDR report key: 2821735
·
Received November 6, 2012
Report
- Report Number
- 1043534-2012-01484
- Event Type
- Injury
- Date Received
- November 6, 2012
- Report Date
- October 8, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE 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 EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4).
Description of Event or Problem · 1
ALLEGEDLY HEAD BREAKAGE AFTER TRAUMA. THE PATIENT SAID HE FELL DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA HEAD | HIP COMPONENT, CODE:MRA | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. | S10118629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |