MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 12MM DIA 100MM L STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Catalog Number	00598801012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has continuing pain, swelling, synovitis and difficulty ambulating six years, seven months post implantation.An arthroscopic procedure was completed six years post implantation however symptoms persisted.No additional information provided by patient at this time.
Additional Manufacturer Narrative
(b)(4).Suggested code (annex g)- mechanical (g04) - stem.Customer 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.Additional associated products: (b)(6), nexgen distal femoral augment block lot# 63661850; (b)(6), nexgen all poly patella std cemented size 32mm dia 8.5mm thick lot# 64107592; (b)(6), nexgen 14mm dia¿¿100mm l offset stem extension lot# 63810697; (b)(6), nexgen left size e cemented option femoral component lot# 63939477; (b)(6), nexgen 12mm h size e,f w/locking screw green articular surface lot# 63564388; (b)(6), nexgen size 5 precoat stemmed a/p wedged tibial component lot# 63814253.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.No devices or photographs were received; therefore, the condition of the components is unknown.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.No compatibility issues were noted.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 12MM DIA 100MM L STRAIGHT STEM EXTENSION
• 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: 21597609
• Report Number: 0002648920-2025-00070
• Device Sequence Number: 9034695
• Product Code: JWH
• UDI-Device Identifier: 00889024220966
• UDI-Public: (01)00889024220966(17)270531(10)63687921
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/24/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00598801012
• Device Lot Number: 63687921
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2017
• 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: Female