FDA Adverse Event Injury Summary report: N

CONTOUR RECONSTRUCTION RING

MDR report key: 6067063 · Received October 31, 2016

Report

Report Number
1020279-2016-00839
Event Type
Injury
Date Received
October 31, 2016
Report Date
October 3, 2016
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDJ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

WHILE PERFORMING A LITERATURE REVIEW (CROCKARELL JR, JR. INTERMEDIATE-TERM RESULTS WITH A MODIFIED ANTIPROTRUSIO CAGE IN ACETABULAR REVISION SURGERY. AM J ORTHOP (BELLE MEAD NJ). 2009;38(9):E144-148.)FOR THE CONTOUR ACETABULAR RINGS, THE FOLLOWING INCIDENT WAS FOUND: A DEVICE WAS REPORTED TO HAVE FRACTURED, RESULTING IN A REVISION OF THE HIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
718674 CONTOUR RECONSTRUCTION RING PROSTHESIS, HIP, ACETABULAR MESH JDJ SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R