MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL PLATE SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen option cemented femoral component size e right catalog #: 00576401552 lot #: 65290758, nexgen option cemented femoral component size e left catalog #: 00576401551 lot #: 65484733, nexgen articular surface size ef 10mm catalog #: 00596403210 lot #: 65329762, nexgen standard cemented all poly patella size 32mm catalog #: 00597206532 lot #: 65270039, nexgen standard cemented all poly patella size 32mm catalog #: 00597206532 lot #: 64774907.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It is reported that the patient is experiencing pain and difficulty putting weight on the leg following knee arthroplasty.No surgical intervention has been performed at this time.Additional information is not available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b3, b4, b5, b6, b7, g3, g6, h2, h3, h4, h6, h11.Review of medical records confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain with ambulation, swelling and tibial component loosening.Initial operative notes note no intraoperative complications.Revision operative notes noted that the femoral and patellar components were found to be well-fixed.However, while performing the synovectomy, the tibial component was found to be grossly loose at the implant/cement interface and was easily removed.All components were revised with the exception of the patella and no intraoperative complications were noted.

• Brand Name: NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL PLATE SIZE 4
• 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: 20770564
• Report Number: 0001822565-2024-03689
• Device Sequence Number: 8182033
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)300716(10)J6823427
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598603702
• Device Lot Number: J6823427
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female