MAUDE Adverse Event Report: ZIMMER NEXGEN ALL POLY PATELLA

Catalog Number 00597206532

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

It is reported that the patella appeared to be discolored when opened.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN ALL POLY PATELLA
• Manufacturer (Section D): ZIMMER; route #1, km. 123.4, bldg. #1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4046960
• MDR Text Key: 4866744
• Report Number: 2648920-2014-00219
• Device Sequence Number: 1
• Product Code: JWH
• 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: 07/28/2014

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: 05/31/2022
• Device Catalogue Number: 00597206532
• Device Lot Number: 62710286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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