MAUDE Adverse Event Report: ZIMMER INC N-K FLEX PROLONG ULTRACONGRUENT ART SURFACE; MBH

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that upon opening, a hair was found in the packaging.

Manufacturer Narrative

This report is being amended to reflect changes in sections.This report will be amended when our investigation is complete.

Manufacturer Narrative

The articular surface was returned with its open packaging for review.As received, a hair was identified on the component inside the packaging.This device is used for treatment.A product history search identified no other complaints for this part and lot combination.Existing packaging procedures provide instructions for gowning and clean room practices and includes a 100% visual inspection of the packaged product.Previous investigation concluded that while a single hair can potentially elevate the overall bioburden of the product, the sterilization and validation to a sterility assurance level of 1.0 x 10-6 gives a high degree of confidence that the debris (hair) is sterile and poses low risk to the patient.While this event is related to the device packaging, debris in the packaging is addressed through risk documentation and existing procedures.

• Brand Name: N-K FLEX PROLONG ULTRACONGRUENT ART SURFACE
• Type of Device: MBH
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5312198
• MDR Text Key: 34353992
• Report Number: 1822565-2015-02687
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00542801109
• Device Lot Number: 62865922
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1