MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BIPOLAR METAL SHELL; KWY

Model Number N/A

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

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned with the complaint for review.Photo and visual inspections revealed that plastic packaging was found adhered at the polar dome.The device was reported to be a 45mm od bipolar metal shell which was verified to be from a lot manufactured on july 05, 2011 and packaged in a polyethylene bag.The device is used for treatment.This issue has been investigated and addressed through internal corrective and preventive actions.The reported lot number was confirmed to be manufactured prior to corrective and preventative actions taken on december 20, 2012.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

Prior to surgery, the implant was opened and it was noted to have polyethylene adhered to the surface of the implant from the outer plastic bag.

• Brand Name: BIPOLAR METAL SHELL
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5636589
• MDR Text Key: 44580009
• Report Number: 0002648920-2016-00828
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/28/2014

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: 07/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 00500104900
• Device Lot Number: 61824425
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2011
• 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