MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630406
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that attune cr rp insrt sz 4 6mm failed during a primary total knee replacement procedure.The insert was found broken, resulting in the need for a revision to a different insert and prolongation of the surgery.The broken implant was isolated and discarded due to contamination, and the case continued with a new insert.The event led to a corrective invasive procedure for the patient, specifically a device revision, and the product was not available for return as it was disposed of after decontamination.
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 recon described in this report.H11 additional narrative: added: b5.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that, the implants was already implanted in the patient when this occurred.Furthermore, expired date are only visible on the pack.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: failed primary tkr due to the insert being broken.Operation continued, delay.Implant isolated and disposal of due to contamination.Picture of the item attached.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that one side of the attune cr rp insrt sz 4 6mm is fractured.Device shows implantation and explanation sings.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation was performed for the finished device 4001063 number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the attune cr rp insrt sz 4 6mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device 4001063 number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.Corrected: h4.

• Brand Name: ATTUNE CR RP INSRT SZ 4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: 24018957
• Report Number: 1818910-2026-00445
• Device Sequence Number: 12996679
• Product Code: NJL
• UDI-Device Identifier: 10603295047636
• UDI-Public: (01)10603295047636(17)271031(10)4001063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• 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,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: 151630406
• Device Lot Number: 4001063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/18/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/20/2026; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown