FDA Adverse Event Injury Summary report: N

TRILOGY LONGEVITY CONSTRAINED POLY LINER

MDR report key: 4212952 · Received October 24, 2014

Report

Report Number
1822565-2014-01448
Event Type
Injury
Date Received
October 24, 2014
Date of Event
July 27, 2014
Report Date
September 24, 2014
Manufacturer
ZIMMER, INC.
Product Code
KWZ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PT WAS REVISED DUE TO RECURRENT DISLOCATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
678890 TRILOGY LONGEVITY CONSTRAINED POLY LINER KWZ ZIMMER, INC. 62036279

Patients

Seq Age Sex Outcome Treatment
1 80 YR Required Intervention LOT # 62082906, REMAINS IMPLANTED| LOT# 62381683 MFR BY ZIMMER (B)(4)| IMPLANTED| TM SHELL WITH MULTI HOLES, CATALOG# 00620205220,| VERSYS FEMORAL HEAD, CATALOG # 00801802814,