FDA Adverse Event
Injury
Summary report: N
FS MIS UNI FEM COMP L LM/RL
MDR report key: 318535
·
Received March 1, 2001
Report
- Report Number
- 9610726-2001-00009
- Event Type
- Injury
- Date Received
- March 1, 2001
- Date of Event
- January 12, 2001
- Report Date
- January 16, 2001
- Manufacturer
- STRYKER HOWMEDICA OSTEONICS
- Product Code
- HSX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REVISION SURGERY HAS BEEN REPORTED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8766 | FS MIS UNI FEM COMP L LM/RL | INSTRUMENT | HSX | STRYKER HOWMEDICA OSTEONICS | NA | LKXFS1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |