MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE; KNEE FEMORAL

Catalog Number	150440109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had been doing well and presented in an outside facility with suspected infection while on vacation.A wound vac was placed and patient returned to his treating surgeon for care.All components were well functioning and well fixed so no allegation was made against the components.There was no delay nor patient harm was noted.A static apacer was fashioned utilizing lps components with high dose antibiotic cement and placement of resorbable antibiotic beads.This patient has had interventions on the following dates where implants were exchanged and ders were submitted.(b)(6) 2025 (b)(6), (b)(6) 2025 (b)(6).Cement utilized was depuy 2 with gent and hospital owned.His patellar component had been placed on (b)(6) 2022 and retained from his primary tka.Doi: (b)(6) 2025, dor: (b)(6) 2026, affected side: left knee.(b)(4) were created for the first and second revision".All impacted products in these two pc's are part of the same third revision surgery for ongoing infection--in this third revision all products were removed, and an antibiotic spacer was implanted." the knee (with all of the current impacted products except the insert) was discovered to be infected on vacation, treated with a wound vac, and then surgically treated with a washout & insert exchange on (b)(6) 2025.(b)(4).Then, on (b)(6) 2025, the knee was again revised with a washout & insert exchange--replacing the insert again, all other products remaining the same.(b)(4) finally, on (b)(6) 2026, everything was revised, and an lps insert was placed as an antibiotic spacer.(b)(4) are the i&d.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: 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.Device history lot: there is 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.Added : d10 concomitant.

• Brand Name: ATTUNE
• Common Device Name: KNEE FEMORAL
• 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 ; 9083863534
• MDR Report Key: 25189658
• Report Number: 1818910-2026-08865
• Device Sequence Number: 21521373
• Product Code: JWH
• UDI-Device Identifier: 10603295042228
• UDI-Public: (01)10603295042228(17)310430(10)JD6954
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 150440109
• Device Lot Number: JD6954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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: ATTUNE CRS FEMORAL LT SZ 9 CEM; ATTUNE CRS RP INSRT SZ 9 16MM; ATTUNE DIST FEM AUG SZ 9 12MM; ATTUNE POS FEM AUG SZ 9 4MM; ATUN FEM SLV M/L 55MM FULL POR; ATUN REV RP TIB BASE SZ 10 CEM; ATUN TIB SLV M/L 53MM FULL POR; ATUNE PRESSFIT STR STEM22X60MM; ATUNE PRESSFIT STR STEM24X60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 163 KG