MAUDE Adverse Event Report: ZIMMER, INC. BIPOLAR CUP

Catalog Number 00500004628

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/24/2014

Event Type  Injury  

Event Description

It is reported that the patient was revised due to the cup migrating causing the patient's acetabulum to fracture.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: BIPOLAR CUP
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3893799
• MDR Text Key: 16860041
• Report Number: 1822565-2014-00742
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00500004628
• Device Lot Number: 69390800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2000
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 54