FDA Adverse Event
Injury
Summary report: N
ENGAGE TAPER DIST BDY 23X240
MDR report key: 1120676
·
Received August 14, 2008
Report
- Report Number
- 1818910-2008-03072
- Event Type
- Injury
- Date Received
- August 14, 2008
- Report Date
- July 17, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K033893
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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
THE PATIENT HAS A FRACTURED HIP STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENGAGE TAPER DIST BDY 23X240 | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | YT4KEA000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |