MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LCCK ART SURF EF 5-6/GRN 12; PROSTHESIS, KNEE

Catalog Number	00599404012
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : france 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.
Event or Problem Description
It was reported that the patient underwent an initial knee surgery on an unknown date.Approximately 2 months post-ptg, it appeared that the patient had external laxity.Subsequently, the patient was revised.During the revision, it was observed that there was a deformity of the posterior stabilization which allowed varus laxity at 15 degrees despite the implant being well clipped and screwed in.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a2; a3a; a4; b1; b4; b5; b7; d2; d6a; d10; g1; g3; g6; h1; h2; h6.D10: 00598801013 - 13mm diameter 100mm length straight stem extension combined length 145mm - unknown.00599401691 - left size f cemented option femoral component femoral plastic cap must be removed prior to implantation - unknown.00598801010 - 10mm diameter 100mm length straight stem extension combined length 145mm - unknown.00598004702 - stemmed tibial component precoat size 6 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - unknown.42540000032 - all poly patella cemented 32 mm diameter - unknown.Customer has indicated that the product is in process of being 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 further reported that the patient underwent an initial left knee surgery.The patient reported severe pain approximately 3-4 weeks post-op, although they were ambulating without their cane.Subsequently, the patient was revised due to recurrent varus instability and pain.A complete replacement of the rhk hinge prosthesis was performed.There was observed poly wear as the implant had deformation in 2 places on the cck posterior stabilization.There were no obvious traumatic causes.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6; h10 the event is confirmed.Visual examination of the returned product show signs of wear surface scratches/gouges /nicks.The dovetail side of the bearing exhibits wear with nicks near the insert.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified widening of the lateral femorotibial joint space consistent with disruption of lateral collateral ligaments and showed loosening of the tibial tray at the cement bone interface.A definitive root cause cannot be determined.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
It was further reported that x-rays suggested tibial loosening prior to the revision surgery.Attempts have been made and all available information has been provided.

• Brand Name: NEXGEN LCCK ART SURF EF 5-6/GRN 12
• 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: 22588618
• Report Number: 0001822565-2025-02641
• Device Sequence Number: 9052361
• Product Code: JWH
• UDI-Device Identifier: 00889024635814
• UDI-Public: (01)00889024635814(17)290806(10)66793369
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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 Catalogue Number: 00599404012
• Device Lot Number: 66793369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG