MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/12/2023
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 #: 64364012, nexgen standard cemented all poly patella size 29mm catalog #: 00597206529 lot #: 63436585, nexgen articular surface size ef 10mm catalog #: 00596403210 lot #: 64464847.G2 - report source - foreign: event occurred in the united kingdom.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address tibial component loosening approximately three (3) years and three (3) months post-operatively.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a4, b4, b5, b6, b7, e1, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address tibial component loosening and pain approximately three (3) years and three (3) months post-operatively.Initial and revision operative notes noted no intraoperative complications.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records provided 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
No further event information available at the time of this report.

• Brand Name: NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20418423
• Report Number: 0002648920-2024-00318
• Device Sequence Number: 15506415
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)29430(10)64391450
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2025

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: 00598603701
• Device Lot Number: 64391450
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 02/26/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/18/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 93 KG