FDA Adverse Event Injury Summary report: N

CONTINUUM SHELL WITH CLUSTER HOLES

MDR report key: 2994417 · Received March 5, 2013

Report

Report Number
1822565-2013-00434
Event Type
Injury
Date Received
March 5, 2013
Report Date
February 5, 2013
Manufacturer
ZIMMER, INC.
Product Code
LZO
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

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 IS EXPERIENCING PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
93883 CONTINUUM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 61629554

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention MFG BY ZIMMER (B)(4).| BIOLOX DELTA HEAD: CAT# 00877504002, LOT#2363776| LOT# 60113523| ZIMMER M/L FEMORAL STEM: CAT#00771101120,