MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER MAXERA CUP SHELL AND CERAMIC LINER

Catalog Number 00151505240

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 11/13/2014

Event Type  Injury  

Event Description

It is reported that the pt was revised due to a displaced shell.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER MAXERA CUP SHELL AND CERAMIC 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: 4360540
• MDR Text Key: 5233877
• Report Number: 1822565-2014-01779
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 00151505240
• Device Lot Number: 62596163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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): Required Intervention