FDA Adverse Event
Malfunction
Summary report: N
1043534-2012-01060
MDR report key: 2755898
·
Received September 24, 2012
Report
- Report Number
- 1043534-2012-01060
- Event Type
- Malfunction
- Date Received
- September 24, 2012
- Date of Event
- January 25, 2006
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- PMA / PMN Number
- P030027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING A RETROSPECTIVE REVIEW, THIS WAS DETERMINED TO BE A REPORTABLE MALFUNCTION. THIS IS THE SAME EVENT AS 1043534-2012-01148.
Description of Event or Problem · 1
FRACTURED FEMORAL HEAD IMPLANT. ALLEGEDLY LINER FRACTURED DURING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |