MAUDE Adverse Event Report: ZIMMER BIPOLAR METAL SHELL

Catalog Number 00500104600

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2014

Event Type  malfunction  

Event Description

It is reported the surgeon was unable to insert the head due to the retentive ring of the cup sticking.The surgery was completed with another bipolar cup.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: BIPOLAR METAL SHELL
• Manufacturer (Section D): ZIMMER; turpeaux industrial park; route 1, km. 123.4, bldg. 1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER; turpeaux industrial park; route 1, km. 123.4, bldg. 1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4127593
• MDR Text Key: 20296639
• Report Number: 2648920-2014-00249
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 00500104600
• Device Lot Number: 62618924
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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