FDA Adverse Event Injury Summary report: N

GII

MDR report key: 3932992 · Received July 14, 2014

Report

Report Number
1020279-2014-00421
Event Type
Injury
Date Received
July 14, 2014
Date of Event
June 19, 2014
Report Date
July 3, 2014
Manufacturer
SMITH&NEPHEW, INC
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PEFORMED. THE CAUSE OF THE REVISION IS UNKNOWN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
410682 GII FEMORAL COMPONENT JWH SMITH&NEPHEW, INC

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R