MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number	545050501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: dmf# - (b)(4).Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements.A1: patient id reported as (b)(6).
Event or Problem Description
Subject id: (b)(6).Study no: oasis prod.Clinical adverse event received for revision ¿ infection.Device and procedure (relatedness).Device related: no information provided.Procedure related: no information provided.Date of event: (b)(6) 2025.Date of implant: (b)(6) 2025.Date of revision: (b)(6) 2025.Device location: left.Treatment/impact: depuy synthes components removed (femoral and tibial components).

• Brand Name: SMARTSET GMV 40G US EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24200714
• Report Number: 1818910-2026-01739
• Device Sequence Number: 21238789
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: (01)10603295174295(17)270430(10)4682725
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 4682725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 110 KG