MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN TIBIAL AUGMENT BLOCK

Catalog Number 00598800726

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

It is reported that upon opening, it was noticed there was a hole in the interior plastic bag the implant was packaged in.Furthermore, there were two small white objects directly on the implant within the plastic bag.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN TIBIAL AUGMENT BLOCK
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4099239
• MDR Text Key: 4756020
• Report Number: 1822565-2014-01053
• 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: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 00598800726
• Device Lot Number: 60640666
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2007
• 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