MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4; PROSTHESIS, KNEE

Catalog Number	00598603702
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00599601501, femoral component option for cemented use only size e, lot: 64924123.00597206532, all poly patella standard cemented size 32 mm diameter 8.5 mm thickness, lot: 64740061.00596403212, articular surface size ef 12 mm height "use with plate 3, lot: 64741817.G2: foreign - event occurred in united kingdom.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 through legal notification that approximately 4 years post implantation of a left total knee arthroplasty, the patient underwent revision due to tibial loosening, presenting in pain, swelling, hot skin, and stiffness.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.The reported event could not be confirmed due to lack of product return and medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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 additional information to report at this time.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4
• 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: 23870883
• Report Number: 0001822565-2025-04725
• Device Sequence Number: 20169407
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)300305(10)J6758145
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: 00598603702
• Device Lot Number: J6758145
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female