FDA Adverse Event
Injury
Summary report: N
CORAIL2 NON COL HO SIZE 11
MDR report key: 2240975
·
Received September 9, 2011
Report
- Report Number
- 1818910-2011-17715
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- March 8, 2010
- Report Date
- August 25, 2011
- Manufacturer
- DEPUY FRANCE
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, CATALOG #/LOT #. 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. (B)(4).
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.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN.
Description of Event or Problem · 1
REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORAIL2 NON COL HO SIZE 11 | FEMORAL STEM | KWY | DEPUY FRANCE | 2275026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |