MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS FLEX ART SURF EF3 4 10; PROSTHESIS, KNEE

Catalog Number	00596203210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 5 years post implantation of a right total knee arthroplasty, the patient was experiencing pain and underwent a revision of the articular surface component.Attempts for additional information have been made and none is available.
Additional Manufacturer Narrative
(b)(4).D10: 00576401652, femoral component option for cemented use only size f right, lot 63653170 00597206532, all poly petella standard cemented size 32 mm diameter 8.5 mm thickness, lot 64398655.00598003702, stemmed tibial component precoat size 4 for cemented use, lot 64012424.G2: event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6.The reported event was unable to be confirmed with the information provided.No product returned or pictures provided; visual and dimensional evaluations could not be made.No medical records were provided.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.
Event or Problem Description
No additional information to report.

• Brand Name: NEXGEN LPS FLEX ART SURF EF3 4 10
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22994430
• Report Number: 0001822565-2025-03335
• Device Sequence Number: 9090341
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)240331(10)64316026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 00596203210
• Device Lot Number: 64316026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female