MAUDE Adverse Event Report: ZIMMER, INC. GENDER SOLUTIONS N-K FLEX PROLONG HIGHLY CROSSLINKED POLY ARTICULAR SURFACE; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.Product received but not yet evaluated.

Event Description

It is reported that upon removal of the inner seal, it was noticed that a piece of hair was stuck to the top of the articular surface.The surgery was completed with another articular surface.

Manufacturer Narrative

Visual inspection of the returned device confirms the presence of dark hair on the articular surface.It cannot be determined with certainty when the hair fell into the packaging.The sterile implant and instrument packaging operating procedure is in place to reduce the likelihood of hairs from being introduced into the packaging and was followed to package this device according to the device history file.The sterilization process for this device complies with fda regulations and iso standards to a sterility assurance level (sal) of 1.0 x 10(-6) or better.The manufacturing lot specified in this complaint was processed according to the sterilization process parameters and met all the acceptance criteria for sterility release.Therefore, it is highly unlikely that the presence of a hair in the package would lead to any infections or other bio-incompatibility if the device had been used.The device history records of the device were reviewed and identified no deviations or anomalies.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combination.A definitive root cause for the reported issue cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GENDER SOLUTIONS N-K FLEX PROLONG HIGHLY CROSSLINKED POLY ARTICULAR SURFACE
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5876705
• MDR Text Key: 52125229
• Report Number: 0001822565-2016-02810
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00542401311
• Device Lot Number: 62057260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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