MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	00596203210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately one (1) year and three (3) months post-implantation, the patient experienced buckling of the knee followed by pain.Subsequently, the patient underwent revision surgery in which the articular surface was replaced for a larger size.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: stemmed tibial component precoat size 3: catalog#00598003701, lot#j6828726; lps flex femoral component size e left: catalog#00596801551, lot#65117559.G2: foreign - event occurred in germany.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to 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 at time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• 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: 24006589
• Report Number: 0001822565-2026-00104
• Device Sequence Number: 17365443
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)270403(10)65329711
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 65329711
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Unknown