MAUDE Adverse Event Report: ZIMMER UNKNOWN ZIMMER ACETABULAR BIPOLAR SHELL; KWY

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

Patient Problem No Information (3190)

Event Date 11/08/2013

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation as it was implanted.The lot number is unknown.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.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 plastic inner packaging of the bipolar shell was melted and stuck to the metal outer surface of the shell.Plastic had to be scraped off the surface before implanting.Surgery was extended five minutes.

• Brand Name: UNKNOWN ZIMMER ACETABULAR BIPOLAR 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; mercadita, 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5573223
• MDR Text Key: 42517815
• Report Number: 2648920-2016-00117
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2013

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2013
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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