MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN OPTION ST TIB PLT SIZE 5; PROSTHESIS, KNEE

Catalog Number	00598604701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00576401652 - lps-flex gsf opt sz f-r - (b)(6).00597206535 - all poly petella standard cemented size 35 mm diameter 9.0 mm thickness - (b)(6).00596404014 - articular surface size ef 14 mm height ''use with plate 5 - (b)(6).Unknown - unknown cobalt high viscosity cement - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by legal a patient underwent a right knee arthroplasty.Approximately 4.5 years post-op, the patient is scheduled to be revised due to loosening.Attempts have been made and all available information has been provided.
Event or Problem Description
It was further reported that the patient was revised due to tibial loosening and pain approximately 4.5 years post-op.The tibial component was found to be grossly loose with no cement adhered to the titanium surface.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: a4; b3; b4; b5; b7; d2; d6a: e1; g1; g2; g3; g6; h1; h2; h6.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgical note noted no intra-op complications.Revision operative notes noted that the patient presented with increased pain.The diagnostic workup confirmed aseptic loosening of the tibial component.The femoral & patellar component found well-fixed, and the tibial component found grossly loose.Postop x-ray confirmed no evidence of fracture or complications.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
No further event information available at the time of this report.
Event or Problem Description
It was further reported that while there was no adhesion of the bone cement to the tibial component, the cement was well adherent to the underlying bone.The patellar component was left intact, and all other components were revised without complication.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; b7; b5; d2; g1; g3; g6; h1; h2 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: NEXGEN OPTION ST TIB PLT SIZE 5
• 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: 23509233
• Report Number: 0001822565-2025-04036
• Device Sequence Number: 9667094
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857(17)300529(10)J6796395
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00598604701
• Device Lot Number: J6796395
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 02/06/2026; 03/25/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/16/2025; 02/24/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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
• Patient Weight: 99 KG