MAUDE Adverse Event Report: ZIMMER ZIMMERF MULTIPOLAR BIPOLAR CUP LINER

Catalog Number 00500104226

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

It is reported that the locking ring was outside of the liner upon opening.The surgeon used another liner to complete the procedure.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The bipolar liner was returned for review with the split poly ring partially disassembled.Dimensional analysis determined that both the liner and split poly ring were separately conforming to print specifications.The split poly ring successfully mates with the liner and the device functions as intended; there are no nonconformances identified, therefore an investigation run by the manufacturing site is not necessary.The device was intended to be used as a treatment to a disease.It is possible that the ring's position had shifted during transit.The device was manufactured in february of 2014 and the event occurred 14 months later.The number of times it has been transported is unknown, however its distribution did include international transit which could have subjected it to movements and vibrations which caused the split poly rings to shift.No additional complaints have been received from this manufacturing lot.With the information provided, no failure is found.

• Brand Name: ZIMMERF MULTIPOLAR BIPOLAR CUP LINER
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer (Section G): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4798244
• MDR Text Key: 16308416
• Report Number: 2648920-2015-00181
• 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: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 00500104226
• Device Lot Number: 62603758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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