FDA Adverse Event
Death
Summary report: N
PROFEMUR® LONG MODULAR NECK
MDR report key: 19034523
·
Received April 3, 2024
Report
- Report Number
- 3010536692-2024-00158
- Event Type
- Death
- Date Received
- April 3, 2024
- Report Date
- November 18, 2025
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
ALLEGEDLY, MODULAR NECK BROKE, REASON UNKNOWN.
Description of Event or Problem · 0
ALLEGEDLY, MODULAR NECK BROKE, REASON UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1447267 | PROFEMUR® LONG MODULAR NECK | HIP COMPONENT | LZO | MICROPORT ORTHOPEDICS INC. | PHAX12X4 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |