MAUDE Adverse Event Report: ZIMMER PERSONA STEMMED CEMENTED TIBIAL COMPONENT

Catalog Number 42532006702

Device Problem Material Discolored (1170)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

It is reported that upon opening the implants for surgery, a discoloration was seen on both devices.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: PERSONA STEMMED CEMENTED TIBIAL COMPONENT
• 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: 4426859
• MDR Text Key: 19798280
• Report Number: 2648920-2015-00012
• 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: 12/15/2014

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 Catalogue Number: 42532006702
• Device Lot Number: 62852088
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• 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
• Treatment: (B)(4); CAT# 42500606402, LOT #62701740, MANUFACTURED BY; PERSONA PS CEMENTED FEMORAL COMPONENT: