FDA Adverse Event
Malfunction
Summary report: N
TOTAL HIP
MDR report key: 456235
·
Received April 24, 2003
Report
- Report Number
- MW1028242
- Event Type
- Malfunction
- Date Received
- April 24, 2003
- Date of Event
- January 17, 2003
- Report Date
- April 10, 2003
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY INC.
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REP FROM WRIGHT MEDICAL TECHNOLOGY, INC. ATTENDING THE TOTAL HIP SURGERY BROUGHT THE WRONG FEMORAL HEAD (NON FINE-FINSHED) FOR THE HIP SOCKET INTO THE OPERATING ROOM, WHICH WAS PLACED INTO THE PT. WRIGHT MEDICAL CONTACTED THE SURGEON AT 7:00PM 3 DAYS LATER TO ADVISE HIM THEY DISCOVERED THE MISTAKE. PT WAS NOTIFIED IN 01/2003 AND SCHEDULED FOR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL HIP | TOTAL HIP | JDI | WRIGHT MEDICAL TECHNOLOGY INC. | NA | 100A123448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |