MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION; KNEE PROSTHESIS

Catalog Number	00596204012
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: pn 00598004701, ln 66121690.Stemmed tibial component.G2 foreign: china.Customer has indicated that the product will 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 the liner would not assemble with the mating tibial tray.There was a 20 mins delay.Finally surgeon used size 10mm liner to complete the surgery.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified signs of insertion attempt (gouges) and the dovetail feature is flared and compressed.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.The reported products were reviewed for compatibility with no issues noted.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as use error.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for proper bearing insertion are provided in the ¿nexgen lps fixed bearing knee surgical technique¿ (1393.2-glbl-en-issue date 2021-12-14) under ¿bearing insertion¿ (pg.47).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 information is available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION
• Common Device Name: KNEE PROSTHESIS
• 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: 22519983
• Report Number: 0001822565-2025-02558
• Device Sequence Number: 8927956
• Product Code: MBH
• UDI-Device Identifier: 00889024666108
• UDI-Public: (01)00889024666108(17)291010(10)66971701
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00596204012
• Device Lot Number: 66971701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Patient Sex: Unknown