MAUDE Adverse Event Report: Zimmer Biomet, Inc. NEXGEN CR-Flex Femoral Component Porous Uncemented Size E Minus (E-) Right; Prosthesis, Knee

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial tka.Subsequently, about 9 years postop, they had a revision due to instability.The surgical technique was utilized.There was no surgical delay.Attempts have been made and no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 00588604514, trabecular metal cruciate retaining monoblock tibial component, 62307308.G2: foreign - event occurred in 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.

• Brand Name: NEXGEN CR-Flex Femoral Component Porous Uncemented Size E Minus (E-) Right
• 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 ; +1(574)526-0384
• MDR Report Key: 50227154
• Report Number: 0001822565-2026-02844
• Device Sequence Number: 13336262
• Product Code: MBH
• UDI-Device Identifier: 00889024259638
• UDI-Public: (01)00889024259638(17)250930(10)63123129
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/10/2026

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 Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 65595201506
• Device Lot Number: 63123129
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 09/14/2015
• 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 Sex: Female