MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 10X63/67MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard femoral left, catalog 183128, lot j3721221; biomet cruciate tray 63mm, catalog 141231, lot j3734099; vanguard femoral pegs set 2, catalog 183099, lot 0827330; series a standard 3 peg patella, 184762, lot 818530; palacos r 1x40 bone cement, catalog 00111214001, lot 83264474.Customer has not indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was experiencing pain and stiffness and subsequently underwent a manipulation under anesthesia approximately six months post left knee arthroplasty due to arthrofibrosis.

Manufacturer Narrative

Office notes provided confirm the patient was experiencing pain and underwent manipulation under anesthesia.No devices or photos were received; therefore the condition of the components is unknown.Device history record was reviewed and no discrepancies were found.Root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information reported.

• Brand Name: VNGD PS TIB BRG 10X63/67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9087935
• MDR Text Key: 162636433
• Report Number: 0001825034-2019-04197
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 183620
• Device Lot Number: 826490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 02/25/2020
• 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: 83