MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX; PROSTHESIS, KNEE

Catalog Number	00596203210
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	06/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00598003701 - stemmed tibial component precoat size 3 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - j6993048 00596801651 - lps flex femoral component-option for cemented use only nitrogen hardened.Size f left - 63715736 00597206529 - all poly patella standard cemented size 29 mm diameter 8.0 mm thickness - 65328250.G2 : foreign country : 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.
Event or Problem Description
It was reported that the patient underwent an initial left knee surgery.Approximately 1 year post-op, the patient was revised due to fixed flexion stiffness.The tibial component was removed and the bone was resected.Attempts have been made and all available information has been provided.

• Brand Name: NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX
• 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: 25815921
• Report Number: 0001822565-2026-02569
• Device Sequence Number: 13412314
• Product Code: JWH
• UDI-Device Identifier: 00889024665989
• UDI-Public: (01)00889024665989(17)290808(10)66852963
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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 Catalogue Number: 00596203210
• Device Lot Number: 66852963
• 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: 06/25/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 95 KG