FDA Adverse Event
Injury
Summary report: N
ULTRA CONG INS RT SZA/13MM NK
MDR report key: 289724
·
Received August 15, 2000
Report
- Report Number
- 2935620-2000-00028
- Event Type
- Injury
- Date Received
- August 15, 2000
- Date of Event
- March 7, 2000
- Report Date
- July 17, 2000
- Manufacturer
- SULZER ORTHOPEDICS INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED: THAT A PT HAD A PRIMARY "NK I: IMPLANTED IN 1997. PRESENTED LATE JUNE WITH LUMPS AROUND ANTERO-LATERAL ASPECT OF TIBIA. THESE WERE PAINFUL AND ON OPERATION, A SYNOVIAL FISTULA WAS FOUND. THE SCREW WAS STILL INSITU AND HAD TO BE UNSCREWED. THE SURGEON HOWEVER IS NOT SURE IF IT WAS TIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA CONG INS RT SZA/13MM NK | KNEE PROSTHESIS | JWH | SULZER ORTHOPEDICS INC. | NA | 93445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization | 13084566) (07/2000).| 3. 6300-07-100 NK II POLY PAT SZ 0/7MM (LOT#| 1302403) (07/2000),| (07/2000),| 2. 6305-00-021 NK NP COCRFEM RTSZ 2 (LOT# 1227870)| 1. 6300-00-420 NK NP STM TIB W/SCW HOLE SZ 2 (LOT# |