FDA Adverse Event
Injury
Summary report: N
BIOMET TOTAL TOE IMPLANT
MDR report key: 35451
·
Received June 25, 1996
Report
- Report Number
- 35451
- Event Type
- Injury
- Date Received
- June 25, 1996
- Date of Event
- May 17, 1996
- Report Date
- June 24, 1996
- Manufacturer
- BIOMET, INC.
- Product Code
- KWH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
JOINT IMPLANT LOOSENED CAUSING PT CONSIDERABLE PAIN IN THE LEFT FIRST TOE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET TOTAL TOE IMPLANT Implant | TOTAL TOE IMPLANT | KWH | BIOMET, INC. | 117107/117112 | 858680/070140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |