FDA Adverse Event
Injury
Summary report: N
PFR 12.0MM X 175MM COCR
MDR report key: 654815
·
Received December 20, 2005
Report
- Report Number
- 1818910-2005-02685
- Event Type
- Injury
- Date Received
- December 20, 2005
- Date of Event
- November 22, 2005
- Report Date
- November 22, 2005
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS REVISED DUE TO FRACTURE OF THE FEMORAL STEM. PT HAS SUFFERED (2) MINOR FALLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFR 12.0MM X 175MM COCR | TOTAL HIP REPLACEMENT | JDD | DEPUY ORTHOPAEDICS, INC. | NA | 374960008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |