FDA Adverse Event Malfunction Summary report: N

SOLUTION HIP FEMORAL PROSTHESIS TOTAL HIP PROSTHESIS

MDR report key: 58551 · Received December 20, 1996

Report

Report Number
1818910-1996-00094
Event Type
Malfunction
Date Received
December 20, 1996
Report Date
November 22, 1996
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Product Code
KWY
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE POROUS COATED FINISH IS COMING OFF THE TOTAL HIP FEMORAL PROSTHESIS THAT WAS IMPLANTED IN A PT. NO OTHER INFO WAS PROVIDED TO CO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SOLUTION HIP FEMORAL PROSTHESIS TOTAL HIP PROSTHESIS Implant TOTAL HIP PROSTHESIS KWY DEPUY ORTHOPAEDICS, INC. NA 889456

Patients

Seq Age Sex Outcome Treatment
1 NO INFO