MAUDE Adverse Event Report: ZIMMER MULTIPOLAR CUP SHELL; KWY

Catalog Number 00500104200

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

Patient Problem No Information (3190)

Event Date 11/17/2013

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Visual inspection concluded that there is polyethylene bag residue on the surface of the device.The product was manufactured in june of 2012.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 (b)(6) 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 surgeon opened the implant during surgery and found the plastic polyethylene wrapper was adhered to the multipolar cup shell surface.

• Brand Name: MULTIPOLAR CUP SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER; turpeaux industrial parkrt. #1; m 123.4, bldg. #1; mercedita 00715
• Manufacturer (Section G): ZIMMER INC.; turpeaux industrial parkrt. #1; km 123.4, bldg. #1; mercedita, 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5573246
• MDR Text Key: 42519174
• Report Number: 2648920-2016-00118
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/19/2013

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 00500104200
• Device Lot Number: 62109137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2013
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2012
• 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