FDA Adverse Event Injury Summary report: N

HIP PROSTHESIS SCREW

MDR report key: 5060782 · Received September 8, 2015

Report

Report Number
1020279-2015-00645
Event Type
Injury
Date Received
September 8, 2015
Date of Event
July 19, 2015
Report Date
July 19, 2015
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

Additional Manufacturer Narrative · 1

.

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A COMPRESSION SCREW THAT HAD BACKED OUT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
592088 HIP PROSTHESIS SCREW JDH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R