FDA Adverse Event Injury Summary report: N

PROMOS HUMERAL

MDR report key: 3140474 · Received May 31, 2013

Report

Report Number
9613369-2013-00044
Event Type
Injury
Date Received
May 31, 2013
Date of Event
August 27, 2009
Report Date
March 15, 2013
Manufacturer
SMITH & NEPHEW, INC.
Product Code
HSD
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

REVISION SURGERY WAS REPORTED DUE TO THE PATIENT FALLING SIX MONTHS POSTOP AND EXPERIENCING INCREASING DISCOMFORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
240723 PROMOS HUMERAL PLUS PROMOS INCLINATION SET 20 MM HSD SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 54 YR Hospitalization| R