FDA Adverse Event
Injury
Summary report: N
CORAIL2 STD SIZE 11
MDR report key: 3082918
·
Received April 29, 2013
Report
- Report Number
- 1818910-2013-05155
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- February 2, 2012
- Report Date
- April 18, 2013
- Manufacturer
- DEPUY FRANCE
- Product Code
- MEH
- PMA / PMN Number
- K042992
- 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. (B)(4).
Additional Manufacturer Narrative · 1
CORRECTED DATA: (MANUFACTURER); (ESTABLISHMENT NAME). 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
IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE RIGHT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184544 | CORAIL2 STD SIZE 11 | HIP STEM | MEH | DEPUY FRANCE | 2069533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |