FDA Adverse Event
Injury
Summary report: N
ULTRA TIB INS RT SZ1/2 9MM NK II
MDR report key: 509121
·
Received January 30, 2004
Report
- Report Number
- 2935620-2004-00006
- Event Type
- Injury
- Date Received
- January 30, 2004
- Date of Event
- December 30, 2003
- Report Date
- January 30, 2004
- Manufacturer
- CENTERPULSE ORTHOPEDICS, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED: PT WAS REVISED FOR RIGHT KNEE IN 2003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA TIB INS RT SZ1/2 9MM NK II | KNEE PROSTHESIS | HSH | CENTERPULSE ORTHOPEDICS, INC. | NA | 1198199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |