MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE; FEMORAL TRIALS

Catalog Number	252303201
Medical Device Problem Codes	Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
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.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 workshops, there were difficulties in mating the fb test tibial bases with the ll/mr wedge tests.According to the report, in some cases it was impossible to get the wedge to be 100% fixed to the tibial test, leaving it slightly loose with a light between both components.In other cases, the wedge screw was fused to the tibial base, making it impossible to disengage.It was reported that it was suspected that some of the participants were being "rough" with the materials.However, after testing, and even though the user was careful, the same thing happened.Additionally, it was reported that the attune knee system revision assembly offset stabilizer x2, broke when the decoupling of the definitive implants was carried out.In both cases, the device broke after coupling and uncoupling approximately 10 times.It was further noted that the use of the device was correct.It was reported that due to the size of the plastic bones, the device worked with tibial bases 4 and 5.The user had problems with using the 6.However, if necessary, it could be used.Was there any harm to the reported patient or user? no.Was there a significant delay? no.

• Brand Name: ATTUNE
• 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: 24957099
• Report Number: 1818910-2026-07358
• Device Sequence Number: 15964539
• Product Code: LXH
• UDI-Device Identifier: 10603295437239
• UDI-Public: (01)10603295437239(10)240912884
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup,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: 252303201
• Device Lot Number: 240912884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/02/2026; 06/30/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/25/2026; 06/03/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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