FDA Adverse Event Injury Summary report: N

R3

MDR report key: 2083578 · Received May 10, 2011

Report

Report Number
1020279-2011-00157
Event Type
Injury
Date Received
May 10, 2011
Report Date
May 29, 2011
Manufacturer
SMITH & NEPHEW, ORTHOPEDICS
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 R3 SHELL JDH SMITH & NEPHEW, ORTHOPEDICS 09DM17616

Patients

Seq Age Sex Outcome Treatment
1 31 YR Hospitalization| R