MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A ASYMMETRIC PAT 31X8; PROSTHESIS, KNEE

Model Number N/A

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 05/21/2020

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 that during a knee revision, the implant packaging was opened and the implant was found to only be vacuum sealed.The inner packaging sterile barrier was missing.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found that the carton only contained the vacuum sealed product and the patient labels were in the tyvek pouch.Further evaluation suggests that the packaging has been opened/modified after manufacturing.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.These products were likely conforming when they left zimmer biomet control.There is no indication that product left zimmer biomet control without sterile package.The condition of the packaging suggests that it was modified after it left zimmer biomet control.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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: SERIES A ASYMMETRIC PAT 31X8
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10162075
• MDR Text Key: 195407719
• Report Number: 0001825034-2020-02386
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304555679
• UDI-Public: (01)00880304555679(17)230106(10)344100
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: N/A
• Device Catalogue Number: 184792
• Device Lot Number: 344100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1