MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV RP TRIAL SIZE 8; TIBIAL BASE PLATES

Catalog Number	250640008
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the impacted product had an unknown allegation.It did not happened in surgery.During manufacturer's investigation of the returned device it was identified that the attune rev rp stem adptr trl assembled with the attune rev rp trial size 8.Additionally, the insert housing was found stripped.
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.Additional narrative: h3, h6: product investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection revealed the attune rev rp stem adptr trl assembled with the attune rev rp trial size 8.Additionally, the insert housing was found stripped.No other cosmetic anomaly was identified on the device surface.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test revealed the attune rev rp stem adptr trl and attune rev rp trial size 8 couldn't be disassembled from one another.Potential cause can be traced to a component failure caused by the damage observed on the insert.The overall complaint was confirmed as the observed condition of the attune rev rp trial size 8 would have contributed to a 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: 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 manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV RP TRIAL SIZE 8
• Common Device Name: TIBIAL BASE PLATES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24575250
• Report Number: 1818910-2026-04579
• Device Sequence Number: 21421393
• Product Code: HWT
• UDI-Device Identifier: 10603295450825
• UDI-Public: (01)10603295450825(10)AB4899679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 250640008
• Device Lot Number: AB4899679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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