FDA Adverse Event
Injury
Summary report: N
CORAIL2 STD SIZE 12
MDR report key: 3834228
·
Received May 28, 2014
Report
- Report Number
- 1818910-2014-19561
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 20, 2014
- Manufacturer
- DEPUY FRANCE SAS-3003895575
- Product Code
- KXA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
ASR REVISION, ASR XL, RIGHT, REASON(S) FOR REVISION: PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313425 | CORAIL2 STD SIZE 12 | HIP FEMORAL STEM/SLEEVE | KXA | DEPUY FRANCE SAS-3003895575 | 2594500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |