FDA Adverse Event
Injury
Summary report: N
NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM
MDR report key: 567262
·
Received January 19, 2005
Report
- Report Number
- 567262
- Event Type
- Injury
- Date Received
- January 19, 2005
- Date of Event
- November 10, 2004
- Report Date
- January 19, 2005
- Manufacturer
- ZIMMER AUSTIN, INC.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WAS REVISED IN 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM | KNEE PROSTHESIS | HSH | ZIMMER AUSTIN, INC. | NA | 1479127 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization | (LOT#1542701) (2004).| 6324-00-100 NK II +4MM MOD B-PLAT CONS SZ0 LF| (LOT#1558664) (2004).| 6215-00-090 NK II REV TIB STM 90MM |