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

Catalog Number	00598801012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: fem size c right: catalog#00588001302, lot#61047563; 17mm height size c articular surface with hinge post extension: catalog#00588003017, lot#61096326; distal femoral augment block precoat may be used with posterior and/or anterior blocks size c 5 mm augment with screw: catalog#00599003310, lot#63255799, qty 2; posterior femoral augment block precoat may be used with distal and/or anterior blocks size c 5 mm augment with screw: catalog#00599003301, lot#ni, qty (b)(4).G2: foreign - event occurred in germany.H6: proposed component code: mechanical (g04) - stem.Diligence is in progress to determine whether the device is available for further evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient began to experience instability in the knee.Diagnostic images revealed a fracture of the femoral component.Subsequently, the patient underwent revision surgery in which the femoral component, femoral stem, and articular surface were replaced without complication.

• Brand Name: NEXGEN 12MM DIAMETER 100MM LENGTH 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: 25032804
• Report Number: 0002648920-2026-00064
• Device Sequence Number: 10127148
• Product Code: JWH
• UDI-Device Identifier: 00889024220966
• UDI-Public: (01)00889024220966(17)300331(10)64648050
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 00598801012
• Device Lot Number: 64648050
• 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: 04/04/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown