MAUDE Adverse Event Report: ZIMMER, INC. NATURAL KNEE II CONSTRAINED FEMUR COMPONENT

Catalog Number 632000203

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 04/19/2014

Event Type  malfunction  

Event Description

It is reported that the femoral component packaging was discovered to be cracked on more than one level, thus rendering the component unsterile.

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.Evaluation summary: the outer carton shows damage that suggests the box was dropped.However, this cannot be confirmed as the damage to the outer carton could have occurred after the product was opened.The box was exposed to a significant impact, likely during transit, outside of the normally anticipated distribution environment.Evaluation codes: device history records were reviewed and found to be conforming.Visual examination of the returned packaging confirmed a fracture to both the inner and outer cavities.The inner cavity is fractured on two opposing sides.The outer cavity is fractured on one of the same sides as the inner cavity.

• Brand Name: NATURAL KNEE II CONSTRAINED FEMUR COMPONENT
• Manufacturer (Section D): ZIMMER, INC.; p.o box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3994769
• MDR Text Key: 4824246
• Report Number: 1822565-2014-00750
• 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: Physician
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 632000203
• Device Lot Number: 61183265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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