MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE; KNEE INSTRUMENTS: ALIGNMENT DEVICE

Catalog Number	254600422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the workshops, there were many difficulties in mating the fb test tibial bases with the ll/mr wedge tests.For example, in some cases it is 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 them.At first, we suspected that some of the participants were being "rough" with the materials.However, we did the test, and even though we were very careful, the same thing happened to us.On the other hand, the 2 pieces (cod 254600422), both from the same batch, broke when the decoupling of the definitive implants was carried out.In both cases, the rupture occurred after coupling and uncoupling approximately 10 times.The use of the device was being correct.The instruments associated with attune revision were used.The reality is that due to the size of the plastic bones, it was worked with tibial bases 4 and 5.I tried the 6 and had problems.No patient involvement.
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 medwatch, a follow-up medwatch will be filed as appropriate.
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE
• Common Device Name: KNEE INSTRUMENTS: ALIGNMENT DEVICE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24969520
• Report Number: 1818910-2026-07495
• Device Sequence Number: 13406820
• Product Code: LXH
• UDI-Device Identifier: 10603295440352
• UDI-Public: (01)10603295440352(10)GM6176407
• 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

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: 254600422
• Device Lot Number: GM6176407
• 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: 06/02/2026; 07/02/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/03/2026; 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown