MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV T AUGTRL 5MM SZ5LL; FEMORAL TRIALS

Catalog Number	252305201
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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 the procedure, the tibial augmentation wedge is assembled to the trial tray, a trial is performed, and when the change is made to test with another height in the wedge, it is evident that it is cold-fused.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, " during the procedure, the tibial augmentation wedge is assembled to the trial tray, a trial is performed, and when the change is made to test with another height in the wedge, it is evident that it is cold-fused." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment ¿source file - (b)(4).The photo investigation revealed that ' 252305201, attune rev t augtrl 5mm sz5ll did not have visible cosmetic defects.The evidence provided was not sufficient to confirm the reported event will be unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.¿ since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the attune rev t augtrl 5mm sz5ll would contribute 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 complaint condition.As part of 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: 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.

• Brand Name: ATTUNE REV T AUGTRL 5MM SZ5LL
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21993559
• Report Number: 1818910-2025-07487
• Device Sequence Number: 11840300
• Product Code: LXH
• UDI-Device Identifier: 10603295437253
• UDI-Public: (01)10603295437253(10)SO2055527
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• 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: 252305201
• Device Lot Number: SO2055527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown