FDA Adverse Event
Malfunction
Summary report: N
CORAIL STEM DAR12 HAC
MDR report key: 727574
·
Received July 29, 2005
Report
- Report Number
- 1818910-2005-01217
- Event Type
- Malfunction
- Date Received
- July 29, 2005
- Date of Event
- June 24, 2005
- Report Date
- July 21, 2005
- Manufacturer
- DEPUY FRANCE S.A.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE PATIENT WAS REVISED DUE TO THE STEM BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORAIL STEM DAR12 HAC | TOTAL HIP PROTHESIS | LPH | DEPUY FRANCE S.A. | NA | 02274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |