MAUDE Adverse Event Report: ZIMMER MULTIPOLAR BIPOLAR LINER

Catalog Number 00500104428

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2014

Event Type  malfunction  

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.

Event Description

It is reported that the liner's diameter was bigger and did not fit in the cup.The internal labeling was stated to not match the external labeling of the opened product.

• Brand Name: MULTIPOLAR BIPOLAR LINER
• Manufacturer (Section D): ZIMMER ; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw , IN 46581-0708 ; 8006136131
• MDR Report Key: 4180850
• MDR Text Key: 46485469
• Report Number: 2648920-2014-00266
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 00500104428
• Device Lot Number: 62695243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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