FDA Adverse Event
Injury
Summary report: N
AML MMA 10.5MM 6.3 IN STEM
MDR report key: 496801
·
Received November 21, 2003
Report
- Report Number
- 1818910-2003-00764
- Event Type
- Injury
- Date Received
- November 21, 2003
- Report Date
- October 23, 2003
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS REVISED DUE TO A BROKEN (RIGHT SIDE) AML STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AML MMA 10.5MM 6.3 IN STEM | TOTAL HIP REPLACEMENT | LPH | DEPUY ORTHOPAEDICS, INC. | NA | 725470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |