MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE AFFIXIUM; KNEE IMPLANT - TIBIAL TRAY

Catalog Number	150621005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that attune fem por cr lt sz 4, attune fb tib base sz 5 por, and atune cr lt ms ins sz 4 5 were involved in a reported event.Following a total knee arthroplasty, the patient developed a postoperative infection, which necessitated irrigation and debridement.Subsequently, a removal surgery was performed, and all implant components were extracted due to uncontrollable infection.Cement molding was completed successfully during the revision procedure.This pc is related to (b)(6) , which reports on the postoperative infection and the debridement.This pc reports on the removal surgery after the debridement.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy synthes(nc) quality system found no nc¿s associated with this product code: 150621005, lot - 4682052 combination.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- a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code: 150621005, lot - 4682052 combination.Added : d10 concomitant.

• Brand Name: ATTUNE AFFIXIUM
• Common Device Name: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 24814998
• Report Number: 1818910-2026-06325
• Device Sequence Number: 12268776
• Product Code: MBH
• UDI-Device Identifier: 10603295507420
• UDI-Public: (01)10603295507420(17)351031(10)4682052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• 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: 150621005
• Device Lot Number: 4682052
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 5 POR.; ATUNE CR LT MS INS SZ 4 5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male