FDA Adverse Event
Injury
Summary report: N
CORAIL AMT COLLAR SIZE 9
MDR report key: 3504170
·
Received December 6, 2013
Report
- Report Number
- 1818910-2013-35310
- Event Type
- Injury
- Date Received
- December 6, 2013
- Date of Event
- August 25, 2013
- Report Date
- October 25, 2013
- Manufacturer
- DEPUY FRANCE SAS REG. # 3003895575
- Product Code
- KWY
- PMA / PMN Number
- PK123991
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Description of Event or Problem · 1
LOOSENING OF CORAIL KHO STEM. UPDATE (B)(4) 2013: PRODUCT/LOT; DOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632932 | CORAIL AMT COLLAR SIZE 9 | FEMORAL HIP STEM | KWY | DEPUY FRANCE SAS REG. # 3003895575 | 5109468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |