MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT THN 31 3 PEG; PROTHESIS KNEE

Model Number N/A

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Based on associated device history records, the product was made to print and correct materials.There was a hair inside of the sterile packaging but outside of the vacuum packaging as stated in the complaint.The seal on the sterile packaging appears to be intact.This issue is being addressed in (b)(4).Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported from zb (b)(6) that during incoming inspection a hair was found inside the sterile pouch.No further information has been provided.

• Brand Name: SERIES A PAT THN 31 3 PEG
• Type of Device: PROTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6941291
• MDR Text Key: 90294232
• Report Number: 0001825034-2017-08485
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 184784
• Device Lot Number: 243400
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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