MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 17MM HEIGHT SIZE C,D WITH LOCKING SCREW YELLOW ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number	00599403017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant medical products: 00599401391 - femoral component - 62979655 00598800300 - tibial component - 63841425 00598801215 - stem extension - 64946306 00598801215 - stem extension - 64881601 66038973 - copal cement - 98381023 66038973 - copal cement - 98381023 66038973 - copal cement - 96634967 66038973 - copal cement - 96634967 g2: foreign - event occurred in australia.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 report will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroscopy on an unknown date.Subsequently, the patient was revised due to stiffness.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11 visual examination of the provided images reveals the explanted articular surface with its post.No damages are visible on the explanted articular surface.No further assessment can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Imaging findings: photo of computer screen showing ap views of the left knee.Total knee arthroplasty with cemented constrained femoral and tibial components.Single partially threaded screw in the medial and lateral tibial plateau suggests prior surgery or arthroplasty.Evaluation for under or overstuffing is limited on a single ap view coned to the knee without standing mechanical axis radiographs or those with the contralateral side.Impression: left total knee arthroplasty without radiographic evidence of hardware loosening or failure.A definitive root cause cannot be determined.This compliant cannot be confirmed.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
No further event information available at the time of this report.

• Brand Name: NEXGEN 17MM HEIGHT SIZE C,D WITH LOCKING SCREW YELLOW ARTICULAR SURFACE
• 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: 22371238
• Report Number: 0001822565-2025-02264
• Device Sequence Number: 18165522
• Product Code: JWH
• UDI-Device Identifier: 00889024224971
• UDI-Public: (01)00889024224971(17)280229(10)64557449
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Catalogue Number: 00599403017
• Device Lot Number: 64557449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female