MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEMORAL-LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during surgery, the implant inner packaging was not sealed.Subsequently, the surgery was completed with a different device.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that there is evidence of proper seal on the outer sterile pouch, and one side of the inner sterile pouch has not been sealed properly.Dhr was reviewed and no discrepancies were found.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.The reported event is being addressed through the capa process.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

No further event information available at the time of this report.

• Brand Name: VANGUARD CR ILOK FEMORAL-LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9797398
• MDR Text Key: 201020225
• Report Number: 0001825034-2020-00992
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183034
• Device Lot Number: J6618567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1