MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM, TRILOGY IT, ALLOFIT IT LINER

Catalog Number 00875201236

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

It is reported that during surgery, it was discovered that a foreign object was on the implant.The surgeon finished the procedure with another device.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Visual inspection of the returned device, could not confirm the presence of the reported unidentified debris.The poly liner was returned in excellent condition; however the original package was not returned.No images were provided of the debris.Device history record review was performed; no deviations or anomalies specific to the reported event were noted.Review of complaint history indicated no previous complaints for the lot code associated with the returned device.This device was packaged in a class 10,000 clean room, under a specially designed hooded packaging station that creates a class 1000 clean room environment that significantly reduces the presence of foreign contaminants.The sterilization process for this device is in accordance with fda regulations and iso standards to a sterility assurance level (sal) of 1.0 x 10(-6) or better.Based on the information provided, a definitive cause for the reported condition could not be determined.

• Brand Name: CONTINUUM, TRILOGY IT, ALLOFIT IT LINER
• 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: 4826981
• MDR Text Key: 5842761
• Report Number: 1822565-2015-00843
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 00875201236
• Device Lot Number: 62546263
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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