FDA Adverse Event
Injury
Summary report: N
CENTRALIGN 2.5 FEM STEM
MDR report key: 350462
·
Received September 5, 2001
Report
- Report Number
- 1822565-2001-00069
- Event Type
- Injury
- Date Received
- September 5, 2001
- Date of Event
- June 26, 2001
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CENTRALIGN FEMORAL COMPONENT LOOSENED AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40214 | CENTRALIGN 2.5 FEM STEM | KWY | ZIMMER, INC. | NA | 07848300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |