FDA Adverse Event
Injury
Summary report: N
CORAIL2 STD SIZE 12
MDR report key: 3101885
·
Received May 9, 2013
Report
- Report Number
- 1818910-2013-05730
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- May 3, 2011
- Report Date
- April 25, 2013
- Manufacturer
- DEPUY FRANCE
- Product Code
- MEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4).
Description of Event or Problem · 1
ASR REVISION. ASR XL - LEFT. REASON(S) FOR REVISION: UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202566 | CORAIL2 STD SIZE 12 | STEM | MEH | DEPUY FRANCE | 1752142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |