MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE OPTION TIBIAL COMPONENT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen standard all poly patella 35mm catalog #: 00597206535 lot #: 64874775, nexgen articular surface size ef 12mm catalog #: 00596404012 lot #: 64795802, nexgen option femoral component size f right catalog #: 00576401652 lot #: 64906624.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 that the patient underwent a right knee arthroplasty revision to address pain and tibial loosening approximately five (5) years post-operatively.During the procedure, the tibial plate was found to be grossly loose with no cement adhered to the titanium surface.No additional information is available.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE OPTION TIBIAL COMPONENT SIZE 6
• 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: 24758596
• Report Number: 0001822565-2026-01050
• Device Sequence Number: 12954879
• Product Code: JWH
• UDI-Device Identifier: 00889024218864
• UDI-Public: (01)00889024218864(17)210727(10)J6797494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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 Expiration Date: 07/27/2021
• Device Model Number: N/A
• Device Catalogue Number: 00598604702
• Device Lot Number: J6797494
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Weight: 99 KG