MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE REV FB TRIAL SIZE 8; ATTUNE STEMMABLE TIBIA INSTRUMENTS : TIBIAL BASE PLATES

Catalog Number	250610008
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a workshop, it was not possible to properly fix the the trial augments in the trial tibiae.It seems that something is wrong with the treads of the trial.They are somehow cold welded.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: during a workshop it was not possible to properly fix the the trial augments in the trial tibiae.It seems that something is wrong with the treads of the trial.They are somehow cold welded.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance at the attune rev fb trial size 8.No damage potentially related to the reported event was observed.The sample only shows signs of a worn appearance consistent with normal and continuous use.The assessment was performed with the returned mating device, and the attune rev fb trial size 8 was successfully assembled without any issues.There were no difficulties observed during the assembling process.The reported condition was not able to be replicated.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune rev fb trial size 8 would have not 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 j&j medtech orthopaedics 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: quantity manufactured: (b)(4).Date of manufacture: 10/28/2024.Any anomalies or deviations identified in dhr: none.Expiry date: n/a.Ifu reference: ifu-0902-00-836.Corrected: h3, h4.

• Brand Name: ATTUNE REV FB TRIAL SIZE 8
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22922084
• Report Number: 1818910-2025-14685
• Device Sequence Number: 15742347
• Product Code: HWT
• UDI-Device Identifier: 10603295435914
• UDI-Public: (01)10603295435914(10)SO2066589
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 250610008
• Device Lot Number: SO2066589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown