FDA Adverse Event
Injury
Summary report: N
ARTICULEZE M HEAD 36MM +5
MDR report key: 3030109
·
Received April 2, 2013
Report
- Report Number
- 1818910-2013-14713
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- February 1, 2013
- Report Date
- June 27, 2013
- Manufacturer
- 8010379 DEPUY INTL., LTD.
- Product Code
- JDI
- PMA / PMN Number
- PK9980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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
THIS IS A DUPLICATE REPORT OF 1818910-2013-12592. THIS REPORT, 1818910-2013-14113, WILL BE REJECTED. 1818910-2013-12592 WILL BE KEPT FOR INVESTIGATION PURPOSES.
Description of Event or Problem · 1
MAUDE REPORT (B)(4) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT WAS REVISED TO ADDRESS PAIN, INABILITY TO BE ACTIVE, METALOSIS, AND COMPLEX FLUID COLLECTION AROUND HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134090 | ARTICULEZE M HEAD 36MM +5 | FEMORAL HEAD | JDI | 8010379 DEPUY INTL., LTD. | YGL91 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |