FDA Adverse Event
Injury
Summary report: N
CORAIL AMT STEM STANDARD KS15
MDR report key: 2011308
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-02485
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- December 22, 2010
- Report Date
- February 4, 2011
- Manufacturer
- DEPUY FRANCE S.A.
- Product Code
- KWA
- PMA / PMN Number
- K042992
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE REPORTED PRODUCT/LOT NUMBER WAS PART OF A BATCH OF PRODUCTS WHICH WERE SUSCEPTIBLE TO FRACTURE. THE ETCH LOCATION WAS CHANGED BY A DESIGN REVISION IN (B)(6) 2002. A RECALL WAS CONDUCTED, IN (B)(6), TO REMOVE ALL AFFECTED PRODUCTS FROM THE MARKET. NOTE - AFFECTED PRODUCT WAS NOT DISTRIBUTED IN THE U.S., AS U.S. DISTRIBUTION DID NOT BEGIN UNTIL (B)(4) 2005. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
NECK FRACTURE OF THE CORAIL AMT STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORAIL AMT STEM STANDARD KS15 | 87KWA | KWA | DEPUY FRANCE S.A. | NA | 1308384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |