FDA Adverse Event
Injury
Summary report: N
KIRSCHNER TOTAL KNEE
MDR report key: 35383
·
Received June 28, 1996
Report
- Report Number
- 35383
- Event Type
- Injury
- Date Received
- June 28, 1996
- Date of Event
- June 14, 1996
- Report Date
- June 24, 1996
- Manufacturer
- KIRSCHNER MEDICAL CORP. ORTHOPAEDIC DIV.
- Product Code
- JWH
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FAILED RIGHT TOTAL KNEE REPLACEMENT ARTHROPLASTY. PLASTIC ON DEVICE FAILED AND DEVICE LOOSENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIRSCHNER TOTAL KNEE | TOTAL KNEE | JWH | KIRSCHNER MEDICAL CORP. ORTHOPAEDIC DIV. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization |