FDA Adverse Event
Injury
Summary report: N
FINN SEGMENTAL FEMORAL
MDR report key: 391035
·
Received April 30, 2002
Report
- Report Number
- 1825034-2002-00044
- Event Type
- Injury
- Date Received
- April 30, 2002
- Date of Event
- February 27, 2002
- Report Date
- April 29, 2002
- Manufacturer
- BIOMET, INC.
- Product Code
- KRQ
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
REVISION LEFT TOTAL ARTHROPLASTY PERFORMED IN 1999. DUE TO PAIN AND INSTABILITY, REVISION PERFORMED IN 2002. SURGEON NOTED ROTATION OF FEMORAL COMPONENT INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINN SEGMENTAL FEMORAL | PROSTHESIS, KNEE, COMP | KRQ | BIOMET, INC. | NA | 026010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |