MAUDE Adverse Event Report: ZIMMER INC CONTINUUM VIVACIT-E NEUTRAL POLY LINER; OQI

Catalog Number 00885101436

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the surgeon was not able to seat the liner correctly without the patient dislocating; an alternate liner was used.

Manufacturer Narrative

Visual inspection of the returned liner confirms that there are gouges near the rim of the liner and scratches on the rim consistent with removal of the liner.Dimensions were found conforming to print specifications where measured.Review of the device history record did not find any deviations or anomalies.This device is used for treatment.Product history search revealed no additional complaints against the related part and lot combination.It is unknown what shell and head was used with the liner.A definite root cause cannot be determined with the information provided.

• Brand Name: CONTINUUM VIVACIT-E NEUTRAL POLY LINER
• Type of Device: OQI
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5315459
• MDR Text Key: 34739526
• Report Number: 1822565-2015-02706
• Device Sequence Number: 1
• Product Code: OQI
• 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,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 00885101436
• Device Lot Number: 63078437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2015
• 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