MAUDE Adverse Event Report: ZIMMER BIPOLAR METAL SHELL; KWY

Catalog Number 00500104600

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

Patient Problem No Information (3190)

Event Date 11/20/2013

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Visual inspection determined that the device has a portion of the polyethylene bag stuck to its polished surface.This issue has been previously investigated and the polyethylene bag used to package this device has demonstrated a propensity to adhere to this implant.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.

Event Description

It was reported that the inside plastic packaging was adhered to the bipolar shell.

• Brand Name: BIPOLAR METAL SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER; turpeaux industrial parkrt.,#1; km 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
• MDR Report Key: 5572925
• MDR Text Key: 42494696
• Report Number: 2648920-2016-00160
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/25/2013

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: 02/14/2022
• Device Catalogue Number: 00500104600
• Device Lot Number: 62004198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2013
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• 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