MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Catalog Number	00596204217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hyperextension (4523); Joint Laxity (4526)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a right total knee arthroplasty on an unknown date followed by a revision due to instability where a zimmer biomet product was implanted.Approximately 7 years post-implantation, the patient underwent another right knee revision due to pain, 3 degrees of hyperextension and global instability in extension, mid flexion, and at 90 degrees in flexion.The poly was upsized to a 20mm condylar constrained knee and all other components were retained.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00111214001 - palacos r 1x40 single - 85214571.00599401792 - right size g cemented option femoral component femoral plastic cap must be removed prior to implantation - 63973516.00598004701 - stemmed tibial component precoat size 5 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 64134389.00599003710 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size g 5 mm augment with screw - 00599003710.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: NEXGEN ARTICULAR SURFACE WITH INSERT AND LOCKING SCREW
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• 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: 24649250
• Report Number: 0001822565-2026-00871
• Device Sequence Number: 9786388
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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: 10/31/2021
• Device Catalogue Number: 00596204217
• Device Lot Number: 63499762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 210 LB