MAUDE Adverse Event Report: ZIMMER MULTIPOLAR BIPOLAR CUP

Catalog Number 00500105100

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It is reported that the locking ring on the cup was not lined up correctly before implanting.The cup was implanted without any issues.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: MULTIPOLAR BIPOLAR CUP
• Manufacturer (Section D): ZIMMER; 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: 3853119
• MDR Text Key: 4658366
• Report Number: 2648920-2014-00074
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/07/2014

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: 05/31/2023
• Device Catalogue Number: 00500105100
• Device Lot Number: 62359217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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