MAUDE Adverse Event Report: ZIMMER BIPOLAR METAL SHELL

Catalog Number 00500104100

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2014

Event Type  Injury  

Event Description

It is reported that the c-ring was stuck inside of the groove of the shell.The surgeon finished the surgery using an alternative shell.

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 MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4024273
• MDR Text Key: 4879867
• Report Number: 2648920-2014-00200
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 00500104100
• Device Lot Number: 61891561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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