FDA Adverse Event
Death
Summary report: N
OSTEONICS UNIVERSAL DISTAL HOLE PLUG
MDR report key: 418317
·
Received September 18, 2002
Report
- Report Number
- 2243265-2002-00093
- Event Type
- Death
- Date Received
- September 18, 2002
- Report Date
- September 13, 2002
- Manufacturer
- HOWMEDICA OSTEONICS
- Product Code
- JDK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE ATTORNEY THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND ALLEGEDLY DIED DUE TO AN "INFECTION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEONICS UNIVERSAL DISTAL HOLE PLUG | IMPLANT | JDK | HOWMEDICA OSTEONICS | NA | 1E1011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |