MAUDE Adverse Event Report: ZIMMER MULTIPOLAR BIPOLAR CUP SHELL

Catalog Number 00500104800

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It is reported that while doing the component assembly, it was noticed that the locking ring in the cup was stuck.

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.This report will be amended when our investigation is complete.

• Brand Name: MULTIPOLAR BIPOLAR CUP SHELL
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4711735
• MDR Text Key: 5652731
• Report Number: 2648920-2015-00126
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/18/2015

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 Catalogue Number: 00500104800
• Device Lot Number: 62739290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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