MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD KNEE SYSTEM PS TIBIAL BEARING E1 ANTIOXIDANT INFUSED; PROSTHESIS, KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant: (b)(6) 2018.Customer has not indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product location is unknown.

Event Description

It was reported the patient was revised due to popping, pain and scrunching noise approximately 1 year post-implantation.Subsequently, the bearing was replaced.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Udi: (b)(4).Concomitant medical products: vngd ps tib brg; p/n: ep-183660, l/n: 388330, biomet ilok pri tib tray; p/n: 141215, l/n: 782270, biomet finned pri stem; p/n: 141320, l/n: 200840, van ps open intl fem-rt; p/n: 183110, l/n: j6285154, series a pat; p/n: 184766, l/n: 594030, biomet bc r; p/n: 110035368, l/n: 745dai1807, biomet bc r; p/n: 110035368, l/n: 745dai1807.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.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 KNEE SYSTEM PS TIBIAL BEARING E1 ANTIOXIDANT INFUSED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8626906
• MDR Text Key: 145601458
• Report Number: 0001822565-2019-02082
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-183660
• Device Lot Number: 388330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 109