FDA Adverse Event Injury Summary report: N

DEPUY HIP IMPLANT

MDR report key: 8102062 · Received November 23, 2018

Report

Report Number
MW5081597
Event Type
Injury
Date Received
November 23, 2018
Date of Event
October 22, 2018
Report Date
November 21, 2018
Manufacturer
DEPUY SYNTHES, INC.
Product Code
KWA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THIS IS AN ONGOING PROBLEM CAUSED BY COBALT/CHROMIUM DEPUY HIP IMPLANT. IT DID NOT START ON A SPECIFIC DATE. METAL ON METAL HIP REPLACEMENT. I AM AN ACTIVE PERSON WALKING AND BIKE RIDING A COUPLE THOUSAND MILES PER YEAR, SO THERE IS A LOT OF METAL DEBRIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
938655 DEPUY HIP IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, (METAL UNCEMENTED ACETABULAR COMPONENT) KWA DEPUY SYNTHES, INC.

Patients

Seq Age Sex Outcome Treatment
1 75 YR Hospitalization| O| S