MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SIZE 4 PRECOAT CEMENTED TIBIAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00588000400
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2 years post implantation of a primary right total knee arthroplasty with a rotating hinge system, the patient began experiencing pain, and subsequently revised due to loosening.All components were exchanged except for the tm cones.Attempts have been made and all information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00588001602, right size f cemented option femoral component, lot # 65789344.00599003620, distal femoral augment block, lot # 64212163.00599003620, distal femoral augment block, lot # 64052763.00598801014, 14mm diameter 100mm length straight stem extension, lot # 65293220.00598801113, long 13mm diameter 155mm length straight stem extension, lot # 63048010.00545001352, trabecular metal tibial cone, large 51x34mm right, lot # 64532793.00588006014, 14mm height size f articular surface with hinge post extension, lot # 65585832.00545001931, trabecular metal femoral diaphyseal cone, 30mm, large, right, lot # 64341203.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 reported event could not be confirmed with the information provided.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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 SIZE 4 PRECOAT CEMENTED TIBIAL COMPONENT
• 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: 23391376
• Report Number: 0001822565-2025-03858
• Device Sequence Number: 9979018
• Product Code: JWH
• UDI-Device Identifier: 00889024199026
• UDI-Public: (01)00889024199026(17)270729(10)65486086
• 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: 2023
• 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
• Report Date (Section B): 12/09/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00588000400
• Device Lot Number: 65486086
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male