FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FEMORAL STEM
MDR report key: 2803255
·
Received October 24, 2012
Report
- Report Number
- 1818910-2012-76627
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- August 20, 2007
- Report Date
- August 15, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE THAT THE PATIENT SUFFERED INCREASING RIGHT HIP PAIN, TENDERNESS, DIFFICULTY STANDING AND WALKING, AND EVENTUALLY NEEDED CRUTCHES FOR AMBULATION. THE PATIENT UNDERWENT AN ASPIRATION OF HIS RIGHT HIP WHICH REVEALED AN INFECTION IN HIS HIP. TWO WEEKS LATER, THE ASR HIP IMPLANT WAS EXPLANTED AND AN ANTIBIOTIC SPACER WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY FEMORAL STEM | FEMORAL STEM HIP IMPLANT | JDI | DEPUY INTERNATIONAL | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |