MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS-FLEX OPTION FEMORAL G-R; PROSTHESIS, KNEE

Catalog Number	00596401752
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent a right knee revision procedure approximately 9 years post-implantation due to pain and inflammation.
Additional Manufacturer Narrative
(b)(4).D6a: implant date was (b)(6) 2016.D10: 00598605701 nexgen option st tib plt size 7 lot# 63283986.00596405010 nexgen lps-flex fxd mld gh/7-10 10mm lot# 63329834.00597206538 nexgen all poly patella 38dia lot# 63289114.G2: great britain.H6: suggested code (annex g)- mechanical (g04) - femur.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated/corrected: b4; b5; g3; h2; h11.Upon receipt of additional information, it was determined that the previously reported device was reported to the incorrect manufacturer number.This event will be reported under mfr 3007963827.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
Upon receipt of additional information, it was determined that the previously reported device was reported to the incorrect manufacturer number.This event will be reported under mfr 3007963827.

• Brand Name: NEXGEN LPS-FLEX OPTION FEMORAL G-R
• 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: 23322011
• Report Number: 0001822565-2025-03774
• Device Sequence Number: 9846039
• Product Code: JWH
• UDI-Device Identifier: 00889024001169
• UDI-Public: (01)00889024001169(17)260630(10)63393300
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P060037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 06/30/2026
• Device Catalogue Number: 00596401752
• Device Lot Number: 63393300
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Male