FDA Adverse Event
Injury
Summary report: N
CORAIL2 STD SIZE 15
MDR report key: 3120548
·
Received May 20, 2013
Report
- Report Number
- 1818910-2013-06054
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- September 12, 2009
- Report Date
- June 21, 2013
- Manufacturer
- DEPUY FRANCE
- Product Code
- MEH
- PMA / PMN Number
- K042992
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE RIGHT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.
Description of Event or Problem · 1
REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION, SOFT TISSUE DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221509 | CORAIL2 STD SIZE 15 | HIP STEM | MEH | DEPUY FRANCE | 1229721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |