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