MAUDE Adverse Event Report: DePuy Ireland - 3015516266 ATTUNE AFFIXIUM; Knee Implant - Tibial Tray

Catalog Number	150621004
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: oasis clinical adverse event received for aseptic loosening of tibia device related: possible procedure related: possible date of event: 13 jul 2026 date of surgery: (b)(6) 2025 operative side: right treatment/impact: diagnostic intervention (specify: revision).
Additional Manufacturer Narrative
(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 narrative: a1: patient id reported as (b)(6).H3, h6: 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.

• 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 ; +1(908)386-3534
• MDR Report Key: 50117827
• Report Number: 1818910-2026-13201
• Device Sequence Number: 18672301
• Product Code: MBH
• UDI-Device Identifier: 10603295507413
• UDI-Public: (01)10603295507413(17)330228(10)JA04A0307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150621004
• Device Lot Number: JA04A0307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 FEM POR CR RT SZ 5; ATTUNE MEDIAL DOME PAT 35MM; ATUNE CR RT MS INS SZ 5 7
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female