MAUDE Adverse Event Report: ZIMMER MULTIPOLAR BIPOLAR CUP LINER; KWY

Catalog Number 00500104026

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

It is reported the locking ring was outside of the liner upon opening.The surgeon mounted the locking ring and attempted using; however, the head didn't' move smoothly and an alternative liner was used.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: MULTIPOLAR BIPOLAR CUP LINER
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER; turpeaux industrial park; route 1, km. 123.4, bldg. 1; mercedita 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4645926
• MDR Text Key: 5753950
• Report Number: 2648920-2014-00289
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 00500104026
• Device Lot Number: 62523166
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• 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