MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD E1 VNGD CR TIB BRG 79/83X12; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - cement simplex tobr 6197-9-001 catalog #: n/a; lot#: mdt030.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Reference reports: 0001825034-2021-02096, 0001825034-2021-02093, 0001825034-2021-02097, 0001825034-2021-02099.

Event Description

It was reported patient underwent a right knee procedure approximately 8 years ago.Subsequently, the patient started feeling a burning sensation along with pain a few months ago.However, no revision procedure has been reported to date.Attempts have been made, but there is no additional information at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.B3 ¿ event date ¿ unknown month and day in 2020.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The results of the investigation are as follows: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.

• Brand Name: VANGUARD E1 VNGD CR TIB BRG 79/83X12
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12165641
• MDR Text Key: 261442449
• Report Number: 0001825034-2021-02098
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K080204
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: EP-183462
• Device Lot Number: 072440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Weight: 82