FDA Adverse Event
Injury
Summary report: N
ARTICULEZE M HEAD 36MM +8.5
MDR report key: 2946354
·
Received February 6, 2013
Report
- Report Number
- 1818910-2013-02215
- Event Type
- Injury
- Date Received
- February 6, 2013
- Report Date
- January 9, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- JDI
- PMA / PMN Number
- K980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
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.
Description of Event or Problem · 1
UPDATE: (B)(4) 2013, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50253 | ARTICULEZE M HEAD 36MM +8.5 | ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS | JDI | DEPUY ORTHOPAEDICS, INC. 1818910 | 1850406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |