FDA Adverse Event
Injury
Summary report: N
1043534-2012-01178
MDR report key: 2754851
·
Received September 21, 2012
Report
- Report Number
- 1043534-2012-01178
- Event Type
- Injury
- Date Received
- September 21, 2012
- Date of Event
- September 8, 2010
- Report Date
- September 19, 2012
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Additional Manufacturer Narrative · 1
PER FDA, REOPENED FILE AS A REPORTABLE MALFUNCTION IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01179.
Description of Event or Problem · 1
ALLEGEDLY, PATIENT SUFFERED A FAILURE OF THE ACETABULAR LINER BY FRACTURING INTO MULTIPLE PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |