MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 6 FOR CEMENTED USE ONLY; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Medical device site infection (4845); Aseptic loosening (4883); Septic loosening (4884)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an initial knee surgery on an unknown date.Subsequently, the patient presented infection and loosening of tibial and femoral components leading to a revision surgery.The surgeon removed all components and replaced them with a spacer.No further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00595204014, articular surface, unknown lot.65595201502, femoral component, 64052009.G2: foreign - event occurred in australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
D10: 00595204014, articular surface, 64458786.65595201502, femoral component, 64052009.00597206532, all poly patella, 65270033.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 or Problem Description
It was reported a patient underwent an initial knee surgery.Subsequently, the patient presented infection and loosening of tibial and femoral components leading to a revision surgery approximately 3 years later.The surgeon removed all components and replaced them with a spacer.No further information has been provided.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 6 FOR CEMENTED USE ONLY
• 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: 23695096
• Report Number: 0001822565-2025-04360
• Device Sequence Number: 21390183
• Product Code: JWH
• UDI-Device Identifier: 00889024217614
• UDI-Public: (01)00889024217614(17)290428(10)J6496165
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 00598004702
• Device Lot Number: J6496165
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 02/10/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/03/2025; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown