FDA Adverse Event Injury Summary report: N

R3 3 HOLE ACET SHELL

MDR report key: 4113624 · Received September 24, 2014

Report

Report Number
1020279-2014-00580
Event Type
Injury
Date Received
September 24, 2014
Date of Event
September 19, 2014
Report Date
September 19, 2014
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SF
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAINFUL HIP AND LIMP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
595580 R3 3 HOLE ACET SHELL 54MM OD JDH SMITH & NEPHEW, INC. 14FM07988

Patients

Seq Age Sex Outcome Treatment
1 73 YR Hospitalization| R 71369894 LOT 14EM21384| 71335754 LOT 14EM09578| 71336500 LOT 13LM18923