FDA Adverse Event
Injury
Summary report: N
DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD
MDR report key: 3050143
·
Received March 15, 2013
Report
- Report Number
- MW5029667
- Event Type
- Injury
- Date Received
- March 15, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS, INC
- Product Code
- JDI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2006. SHE RECEIVED THE DEPUY TOTAL HIP PINNACLE 300 ACETABULAR CUP, SZ MM 52, PINNACLE METAL INSERT 36MMID X 52MMID, AND THE ARTICUL/EZE METAL ON METAL FEMORAL HEAD 36MM +8 12/14 CONE. SINCE HER HIP REPLACEMENT IN 2006, SHE HAS SUFFERED FROM SEVERE PAIN IN HER RIGHT HIP THAT IS SO SEVERE THAT IT IS DIFFICULT TO GET OUT OF BED IN THE MORNING. THE PAIN WORSENS WHEN WALKING, LIMITING HER MOBILITY AND INTERFERING WITH HER DAILY LIFE. REASON FOR USE: AVASCULAR NECROSIS OF RIGHT HIP STATUS POST FEMORAL NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110220 | DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD | METAL-ON-METAL HIP IMPLANT | JDI | DEPUY ORTHOPAEDICS, INC | 1570-02-110 | ZR2F81000 | |
| 110336 | DEPUY PINNACLE 300 ACETABULAR CUP | METAL-ON-METAL HIP IMPLANT | LPH | DEPUY ORTHOPAEDICS, INC | 1217-03-052 | Z45A61000 | |
| 110337 | DEPUY PINNACLE METAL INSERT | METAL-ON-METAL HIP IMPLANT | LPH | DEPUY ORTHOPAEDICS, INC | 121887352 | 2187444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |