MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE OPTION TIBIAL COMPONENT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant devices - nexgen option cemented femoral component size g catalog #: 00599601702 lot #: 64183631, nexgen articular surface size gh 10mm catalog #: 00596405010 lot #: 64204498, nexgen standard cemented all poly patella size 35mm catalog #: 00597206535 lot #: 64450193.G2: report source, foreign: the 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 unknown reasons approximately four (4) years and eight (8) 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: b4, g3, h2, h3, h6.The following section was corrected: d5, h4.The reported event was unable to be confirmed.No devices were received or pictures provided; visual and dimensional evaluations could not be made.Review of the device history record identified no deviations or anomalies during manufacturing.No medical records were provided.A definitive root cause could not be determined.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 additional information to report.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE OPTION TIBIAL COMPONENT SIZE 7
• 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 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: 21366038
• Report Number: 0002648920-2025-00041
• Device Sequence Number: 8451780
• Product Code: JWH
• UDI-Device Identifier: 00889024218871
• UDI-Public: (01)00889024218871(17)290531(10)64431018
• 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: 2020
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/08/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00598605701
• Device Lot Number: 64431018
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Male