MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Attune Implant : Knee Tibial Insert

Catalog Number	151650916
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Age at time of surgery: 72 years.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) 2026.Date of implant: (b)(6) 2026.Date of revision: (b)(6) 2026.Device location: right knee.Treatment/impact: were depuy synthes components removed: yes (femoral and insert).Depuy synthes products used: catalog number: 150410209, lot number: 4281082, component type: femoral, description: attune knee system femoral posterior stabilized size 9 right cemented.Catalog number: 151650916, lot number: 4765786, component type: insert, description: attune knee system tibial insert rotating platform posterior stabilized size 9 16mm aox.
Additional Manufacturer Narrative
Product complaint (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE
• Common Device Name: Attune Implant : Knee Tibial Insert
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50950812
• Report Number: 1818910-2026-16914
• Device Sequence Number: 9624530
• Product Code: NJL
• UDI-Device Identifier: 10603295053057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study
• 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: 151650916
• Device Lot Number: 4765786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2025
• 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: 72 YR
• Patient Sex: Male