FDA Adverse Event
Injury
Summary report: N
ARTICULEZE M HEAD 36MM +8.5
MDR report key: 3050812
·
Received April 10, 2013
Report
- Report Number
- 1818910-2013-15182
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- April 5, 2013
- Report Date
- June 25, 2013
- Manufacturer
- 8010379 DEPUY INTL., LTD.
- Product Code
- JDI
- PMA / PMN Number
- PK980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORT OF 1818910-2013-15287. THIS REPORT, 1818910-2013-15182, WILL BE REJECTED; 1818910-2013-15287 WILL BE KEPT FOR INVESTIGATION PURPOSES.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149840 | ARTICULEZE M HEAD 36MM +8.5 | FEMORAL HEAD | JDI | 8010379 DEPUY INTL., LTD. | 2717713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |