MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN OPTION ST TIB PLT SIZE 4; PROSTHESIS, KNEE

Catalog Number	00598603702
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	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was the reported by legal that the patient underwent an initial right knee arthroplasty.Subsequently, the patient has experienced loosening and is being considered for a revision.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6; h10; h11.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 provided and reviewed state that the patient underwent a right total knee arthroplasty.Operative details note that tibial and femoral components, a 14mm spacer, and a cemented patellar button were implanted with no intraoperative complications.Postoperative imaging confirmed appropriate alignment without fracture or acute abnormality.Per report from legal, the patient has subsequently experienced loosening of the implant, and a revision procedure is planned.A definitive root cause cannot be determined.This compliant cannot 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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11.The reported event was confirmed.Visual examination of the provided picture identified explanted tibia and femur implants.The devices show signs of use such as biological material adhered to the surfaces.The device history record was reviewed and no discrepancies relevant to the reported event were found.Operative notes provided and reviewed state that an initial right knee arthroplasty was completed.The patient later developed pain and was found to have aseptic loosening of the right tibial component.A revision right total knee arthroplasty was performed.During surgery the femoral and patellar components were well fixed, and the tibial component was grossly loose.No intraoperative complications noted.Postoperative radiographs confirmed a right tka with stems in place and no evidence of fracture or acute abnormalities.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b2; b3; b4; b5; b7; d6b; g3; g6; h1; h2; h6.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient was revised approximately 5 years and 7 months post implantation due to loosening.During the revision the patella and femoral components were found to be well fixed, the tibial component was grossly loose.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN OPTION ST TIB PLT SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22004824
• Report Number: 0001822565-2025-01342
• Device Sequence Number: 15731926
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)290809(10)J6568910
• 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: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/09/2025

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: 00598603702
• Device Lot Number: J6568910
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 11/04/2025; 12/03/2025; 12/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/25/2025; 12/01/2025; 12/08/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 83 KG