FDA Adverse Event Injury Summary report: N

R3

MDR report key: 4090659 · Received September 15, 2014

Report

Report Number
1020279-2014-00557
Event Type
Injury
Date Received
September 15, 2014
Date of Event
July 18, 2014
Report Date
August 29, 2014
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

.

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
569727 R3 FEMORAL COMPONENT JDH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization