MAUDE Adverse Event Report: ZIMMER INC ZUK ARTICULAR SURFACE; HSX

Catalog Number 00584202508

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a foreign source 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 that a hair was on the articular surface when the implant was opened.A new implant was opened and used.

Manufacturer Narrative

This report is being amended to reflect changes.Visual inspection of the returned articular surface indicates device is in "like-new" condition.The original packaging was not returned for review as the product was returned in packaging from another device.The alleged hair is not present on the returned product or packaging.Device history records were reviewed and no deviations or anomalies were found.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combination.Zimmer implants are sterilized to meet fda regulations and iso standards at a sterility assurance level (sal) of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the presence of the foreign material found in the package would lead to any infections or other bio-incompatibility if the device had been used.The alleged event cannot be verified; a definitive root cause cannot be determined.

• Brand Name: ZUK ARTICULAR SURFACE
• Type of Device: HSX
• 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: 5032570
• MDR Text Key: 24554859
• Report Number: 1822565-2015-01558
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 00584202508
• Device Lot Number: 62914557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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