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

Catalog Number 00598800326

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It is reported that the inner packaging of the implant had a hole along the bottom of the bag.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN TIBIAL AUGMENT BLOCK
• Type of Device: HSX
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46580 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4092714
• MDR Text Key: 4713943
• Report Number: 1822565-2014-01004
• 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: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 00598800326
• Device Lot Number: 61049914
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2008
• 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
• Patient Age: 65 YR