FDA Adverse Event Injury Summary report: N

BIPOLAR

MDR report key: 3900006 · Received June 27, 2014

Report

Report Number
1020279-2014-00382
Event Type
Injury
Date Received
June 27, 2014
Date of Event
June 24, 2014
Report Date
June 24, 2014
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
377374 BIPOLAR FEMORAL COMPONENT JDH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R