FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 241622
·
Received September 20, 1999
Report
- Report Number
- 241622
- Event Type
- Injury
- Date Received
- September 20, 1999
- Date of Event
- August 25, 1999
- Report Date
- September 17, 1999
- Manufacturer
- UNK
- Product Code
- JEH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
"THE MEDIAL PLATEAU PORTION WAS FOUND TO BE CRACKED AND BROKEN ALONG THE MEDICAL ANTERIOR LIMB OF THE COMPONENT PART."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK Implant | TIBIAL FEMORAL COMPONENT/SCREWS | JEH | UNK | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| O| R |