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

Catalog Number	254500973
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
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 (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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that on b)(6) 2026, the patient underwent tka for knee oa on the right side.At wound closure, when a nurse removed the shim assembled to the device, the metal spring ring used to secure the shim became dislodged (size #4 psrp).The surgery was completed successfully without any surgical delay.Loosening of the same spring ring was confirmed in the size #3 psfb and size #5 perp insert trials.The surgeon confirmed by x-ray that no broken fragments or components remained in the patient¿s body.

• Brand Name: ATTUNE
• Common Device Name: TIBIAL INSERT 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: 25152327
• Report Number: 1818910-2026-08650
• Device Sequence Number: 16138696
• Product Code: HWT
• UDI-Device Identifier: 10603295135500
• UDI-Public: (01)10603295135500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• 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: 254500973
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 06/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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