MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEM EXTENSION; PROSTHESIS KNEE

Catalog Number	00598801013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure thirty months post implantation due to femoral loosening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4) d10 medical devices: rotating hinge knee left size d cemented option femoral component catalog#: 00588001401 lot#: 64549912, rotating hinge knee tm femoral diaphyseal cone 30mm catalog#: 00545001830 lot#: 63770738, rotating hinge knee femoral augment block size d 20 mm catalog#: 00599003424 lot#: 64103993, rotating hinge knee femoral augment block size d 20 mm catalog#: 00599003424 lot#: 77003570.Unknown tibial insert catalog#: ni lot#: ni, palacos r + g (1x40) catalog#: 66022663 lot#: 98091024, unknown tibial tray catalog#: ni lot#: ni.G2 foreign source: australia h6: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that the patient underwent a revision of the femoral rhk components.The previous surgery was a second-stage revision, where a rotating hinge knee (rhk) was implanted.The patient¿s history includes multiple prior interventions, including a poly exchange, vastus lateralis free flap, extensor tendon reconstruction, and washout post-free flap reconstruction.During the revision, the rhk femoral component, femoral augment blocks, trabecular metal femoral diaphyseal cone, and palacos cement were explanted.A new rhk femoral component and simplex cement were implanted.The tibial components and stem extension were retained.X-ray review indicates that minimal radiolucency is observed along the femoral stem.No fracture is identified.The impressions indicate that the radiolucency is nonspecific but could suggest early loosening.The fit and alignment of the implants are deemed appropriate, and mild osteopenia is noted.No other anatomical or implant concerns that would lead to revision were identified.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.

• Brand Name: NEXGEN 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: 21469170
• Report Number: 0002648920-2025-00054
• Device Sequence Number: 3492246
• Product Code: JWH
• UDI-Device Identifier: 00889024220973
• UDI-Public: (01)00889024220973(17)310711(10)65027757
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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
• Device Catalogue Number: 00598801013
• Device Lot Number: 65027757
• 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: 02/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 106 KG