MAUDE Adverse Event Report: ZIMMER, INC. MULTIPOLAR BIPOLAR SHELL

Catalog Number 00500105300

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2014

Event Type  malfunction  

Manufacturer Narrative

Eval summary: review of images confirmed that the shell was returned with only one of the tabs visible through the slot.When both tabs are not in the slot, the locking ring will not expand adequately to accept the liner.This can result in, as described in this complaint, difficulty to insert the liner into the bipolar metal shell.Step by step assembly instructions are provided both in the surgical technique and package insert.There are also instructions for checking the position and condition of the locking ring prior to assembly.The bipolar shell was returned with one tab of the lock ring seized in the lock ring groove of the shell.The lock ring was easily removed and reassembled.Dimensional readings of the lock ring and shell are conforming to print specs.

Event Description

It is reported that the liner would not seat in the cup due to the locking tab of the cup being locked.A new shell was opened and implanted.

• Brand Name: MULTIPOLAR BIPOLAR SHELL
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4180860
• MDR Text Key: 57399113
• Report Number: 1822565-2014-01364
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2014

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 Catalogue Number: 00500105300
• Device Lot Number: 62746446
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 73 YR