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

Catalog Number	150621004
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for revision ¿ aseptic loosening.Device related: no information provided.Procedure related: no information provided.Date of event: (b)(6) 2026.Date of implant: (b)(6) 2025.Date of revision: (b)(6) 2026.Device location: left.Treatment/impact: revision.Depuy synthes products used.Catalog number: 150401104.Lot number: 3793392.Component type: femoral description: attune cr fem lt sz 4 por.Catalog number: 150621004.Lot number: ja04a0460.Component type: tibial.Description: attune fb tib base sz 4 por.Catalog number: 151820406.Lot number: m83k02.Component type: insert.Description: attune left medial stabilized insert size 4 6mm.Catalog number: 151810035 lot number: 4689234.Component type: patel.Ar.Description: attune medial anat pat 35mm.Catalog number: 3322020.Lot number: 4494872.Component type: patellar.Description: smart set bone cement 20g.
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 narrative: a1: 01684-09268.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: 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.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: 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
Additional event information reviewed: treatment/impact: components removed (femoral, insert, tibial, patella).

• 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: 25081152
• Report Number: 1818910-2026-08202
• Device Sequence Number: 10437675
• Product Code: MBH
• UDI-Device Identifier: 10603295507413
• UDI-Public: (01)10603295507413
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Study,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150621004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 95 KG