FDA Adverse Event Injury Summary report: N

CONSERVE(R) TOTAL A-CLASS HEAD

MDR report key: 3974038 · Received August 1, 2014

Report

Report Number
3010536692-2014-01071
Event Type
Injury
Date Received
August 1, 2014
Date of Event
May 2, 2013
Report Date
July 14, 2014
Manufacturer
MICROPORT ORTHOPEDICS INC.
Product Code
JDL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IL, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

Description of Event or Problem · 1

ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS OF LEFT HIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
451136 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 049843741

Patients

Seq Age Sex Outcome Treatment
1 77 YR Required Intervention