MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN OPTION STEMMED TIBIAL PLATE SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - concomitant devices - nexgen lps-flex option femoral component size f right catalog #: 00576401652 lot #: 64906624, nexgen lps-flex articular surface size ef/5-6 12mm catalog #: 00596404012 lot #: 64795802, nexgen all poly patella 35mm catalog #: 00597206535 lot #: 64874775.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient is experiencing unknown post-operative complications approximately five (5) years following a right knee arthroplasty.Initial operative notes noted no intraoperative complications.No additional information is available.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain and tibial aseptic loosening approximately five (5) years post-operatively.Initial operative notes noted no intraoperative complications.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b3, b4, b5, b7, d6b, g3, g6, h2, h6, h11.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The product was evaluated through manufacturing review and medical records provided confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.

• Brand Name: NEXGEN OPTION STEMMED TIBIAL PLATE SIZE 6
• 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: 24608712
• Report Number: 0001822565-2026-00814
• Device Sequence Number: 18725710
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00598604702
• Device Lot Number: J6797494
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 06/18/2026; 06/25/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/08/2026; 06/18/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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; Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 219 LB