MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 12X67; PROSTHESIS, KNEE

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

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

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.A complaint occurred because a staff member reported that the tray was compromised.This cannot be confirmed because a staff member peeled open the tray prior to returning it to biomet.Upon review, the tray displays signs of an adhesive transfer around the edges, which proves that the tray was sealed before it left biomet.However, it cannot be proved that the tray wasn't fully sealed throughout the entire distribution process because the staff member had opened up the tray.Despite all of this, the aluminum oxide pouch which contains the product is completely sealed and the part is vacuum sealed in place.As a result of this, the part is deemed sterile and can function as intended.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined, device analysis indicated that the device met specification.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation under performance validation file #192.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.

Event Description

It was reported that during an initial total knee arthroplasty procedure, the staff opened a plastic sealed implant box and found implant container compromised.The inner seal was not fully sealed.Another poly was available to complete the procedure.No additional patient consequences were reported.

• Brand Name: VNGD ANT STBLZD BRG 12X67
• Type of Device: PROSTHESIS, 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: 6930772
• MDR Text Key: 88866645
• Report Number: 0001825034-2017-08244
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Model Number: N/A
• Device Catalogue Number: 189042
• Device Lot Number: 003760
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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