FDA Adverse Event
Injury
Summary report: N
WRIGHT MEDICAL
MDR report key: 486077
·
Received September 26, 2003
Report
- Report Number
- 486077
- Event Type
- Injury
- Date Received
- September 26, 2003
- Date of Event
- August 19, 2003
- Report Date
- August 27, 2003
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY
- Product Code
- KWF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT PRESENTED TO DR WITH PAINFUL JOINT AFTER ORIGINAL SURGERY IN 2003. PT HAD TO RETURN TO SURGERY TO HAVE IMPLANT REPLACED 6 MONTHS LATER. DR FOUND ORIGINAL IMPLANT WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRIGHT MEDICAL | FINGER JOINT IMPLANT WITH GROMMET SIZE 4 | KWF | WRIGHT MEDICAL TECHNOLOGY | * | 12235760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |