FDA Adverse Event Injury Summary report: N

BIPOLAR

MDR report key: 2070619 · Received April 27, 2011

Report

Report Number
1020279-2011-00141
Event Type
Injury
Date Received
April 27, 2011
Date of Event
April 10, 2011
Report Date
April 27, 2011
Manufacturer
SMITH AND NEPHEW, INC.
Product Code
KWY
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIPOLAR FEMORAL HEAD KWY SMITH AND NEPHEW, INC. 10FM19034

Patients

Seq Age Sex Outcome Treatment
1 72 YR Hospitalization| R