MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM, TRILOGY IT, ALLOFIT IT LINER

Catalog Number 00875201728

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Information (3190)

Event Date 01/19/2015

Event Type  Injury  

Event Description

It is reported that an expired product was implanted.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: CONTINUUM, TRILOGY IT, ALLOFIT IT LINER
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4539129
• MDR Text Key: 5511801
• Report Number: 1822565-2015-00200
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 00875201728
• Device Lot Number: 61396845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR