MAUDE Adverse Event Report: DePuy Ireland ATTUNE; Attune Implant : Knee Tibial Insert

Catalog Number	151650806
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was pain.It did not happen in surgery.Doe: (b)(6) 2026.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information provided, it was reported that there was pain.It did not happen in surgery.Doe: aug 17, 2026 affected side: left knee.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device or additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history lot there is 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.Corrected: d4 primary udi number.

• Brand Name: ATTUNE
• Common Device Name: Attune Implant : Knee Tibial Insert
• Manufacturer (Section D): DePuy Ireland; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50736932
• Report Number: 1818910-2026-15649
• Device Sequence Number: 10633222
• Product Code: NJL
• UDI-Device Identifier: 10603295052852
• UDI-Public: (01)10603295052852(10)4321338
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151650806
• Device Lot Number: 4321338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male