FDA Adverse Event
Injury
Summary report: N
AML MMA 10.5MM 6.3 IN STEM
MDR report key: 441597
·
Received February 7, 2003
Report
- Report Number
- 1818910-2003-00054
- Event Type
- Injury
- Date Received
- February 7, 2003
- Date of Event
- January 10, 2003
- Report Date
- February 7, 2003
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WILL NEED TO BE REVISED DUE TO A FRACTURED STEM. DR. TOOK X-RAYS THREE MONTHS AFTER THE PT COMPLAINED OF PAIN AND DISCOVERED THAT THE STEM WAS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AML MMA 10.5MM 6.3 IN STEM | TOTAL HIP PROSTHESIS | LPH | DEPUY ORTHOPAEDICS, INC. | NA | 592840009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |