FDA Adverse Event
Injury
Summary report: N
BIOMET INC.
MDR report key: 199636
·
Received November 25, 1998
Report
- Report Number
- MW1015066
- Event Type
- Injury
- Date Received
- November 25, 1998
- Date of Event
- November 10, 1998
- Report Date
- November 12, 1998
- Manufacturer
- BIOMET, INC.
- Product Code
- KWY
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FRACTURE OF 9MM RIGHT STEM IMPLANT AS WELL AS RIGHT FEMORAL NECK FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET INC. Implant | FEMORAL POROUS COATED RIGHT STEM | KWY | BIOMET, INC. | 104910 | 500080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |