MAUDE Adverse Event Report: ZIMMER INC ZUK FEMORAL COMPONENT; HSX

Catalog Number 00584201402

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/31/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination did not confirm the presence of polyethylene residue on the implant.The implant was autoclaved before being returned for review.This heat process would likely cause any low density polyethylene ldpe, used to package this device, that adhered to the implant to liquefy, therefore; no ldpe remnants were visualized.The device was used for treatment.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action z-0845-2016 was initiated on january 11, 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the package was opened and plastic was stuck to the implant.The surgeon attempted to remove the plastic with saline and water, but was unsuccessful.Surgery was completed with another device.

• Brand Name: ZUK FEMORAL COMPONENT
• 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: 5572192
• MDR Text Key: 42981174
• Report Number: 1822565-2016-01129
• Device Sequence Number: 1
• Product Code: HSX
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 00584201402
• Device Lot Number: 62086822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0845-2016
• Patient Sequence Number: 1