MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX 12MM SIZE 4; KNEE TIBIAL INSERT

Catalog Number	151710412
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/03/2026
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 report, a follow-up report will be filed as appropriate.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
The poly insert was removed from a patient on (b)(6) 2026 after originally being implanted on (b)(6) 2025.As seen in the xrays the femur had then dislocated from the insert in the weeks following.During the revision procedure once the knee was opened up, it became clear that the post had snapped at the top of the insert, upon manipulation of the articulating surface something seemed not quite correct and the post was fitting too snug in the box in the femur.All sizes were checked (against njr, written on the implants & also measured with calipers) and compatible/correct.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary = > according to the information received, the poly insert pictured above was removed from a patient on (b)(6)2026 after originally being implanted on (b)(6)/25.As seen in the xrays the femur had then dislocated from the insert in the weeks following.During the revision procedure once the knee was opened up it became clear that the post had snapped at the top of the insert, upon manipulation of the articulating surface something seemed not quite correct and the post was fitting too snug in the box in the femur.All sizes were checked (against njr, written on the implants & also measured with calipers) and compatible/correct.The product was not returned to depuy synthes, however photos were provided for review.See attachment (pc-002106259 attune revision poly insert).The photo and radiographic evaluation revealed that the superior portion of the attune crs rp insrt sz 4 12mm exhibits a fracture, resulting in exposure of the metallic pin.Additionally, the articular surface shows generalized wear patterns.This fracture allowed the tibial plateau to slide anteriorly, suggesting some degree of instability and insufficient constraint within the implant.Correlation of the photographic and radiographic findings supports the conclusion that the fracture was a contributing factor to the observed anterior displacement and instability.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence device failure.Consideration must be given to all 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.It is highly recommended to the patient to consult with their healthcare professional for further assessment.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune crs rp insrt sz 4 12mm would have contributed to the complained device issue.Based on the investigation findings, the potential cause cannot be established, and 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 = > the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX 12MM SIZE 4
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND; 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: 24699742
• Report Number: 1818910-2026-05300
• Device Sequence Number: 10046684
• Product Code: NJL
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 151710412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown