MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 5 CEM; KNEE TIBIAL TRAY

Catalog Number	150660005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Unspecified Infection (1930)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for arteritis stade 4 + infection of left tka.Device and procedure (relatedness).Device related: possibly.Procedure related: possibly.Date of event: 16 jul 2025.Date of implant: (b)(6) 2022.Date of revision: no information provided.Device location: left.Treatment/impact: hospitalization (initial or prolonged): yes; was the subject readmitted to hospital: yes (readmission on (b)(6) 2025); injected medication: yes; oral medication: yes; components removed (femoral component, femoral stem, tibial insert, tibial base) depuy synthes products used: catalog number: 150440107.Lot number: jg6793.Component type: femoral component.Description: attune knee system revision crs femoral cemented left size 7.Catalog number: 150660005.Lot number: 3733875.Component type: tibial base component.Description: attune knee system revision rotating platform tibial base cemented size 5.Catalog number: 151710706.Lot number: 9898466.Component type: tibial insert component.Description: attune knee system revision crs rotating platform insert aox size 7 6mm.Concomitant products: catalog number: 66017750.Lot number: 61441115.Component type: cement.Description: no information provided.
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 report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: h3, h6: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.No device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5, d10 (concomitant), h6 (health effect - impact code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Updates received: treatment/impact: other - specify: trans-femoral amputation.
Additional Manufacturer Narrative
Product complaint: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
The following additional event information were reviewed: components removed: n/a.Attune femoral component: yes; no.Attune femoral stem: yes; no.Attune tibial base: yes; no.Attune tibial insert: yes; no.

• Brand Name: ATUNE REV RP TIB BASE SZ 5 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24024460
• Report Number: 1818910-2026-00493
• Device Sequence Number: 13410428
• Product Code: NJL
• UDI-Device Identifier: 10603295042891
• UDI-Public: (01)10603295042891(17)320229(10)3733875
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 150660005
• Device Lot Number: 3733875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 04/14/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/14/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2022
• 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: ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; COMPETITOR BONE CEMENT(66017750/61441115); UNKNOWN KNEE FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 105 KG