MAUDE Adverse Event Report: DePuy Ireland - 3015516266 ATTUNE; Knee Implant - Tibial Insert

Catalog Number	151820708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient was revised due to pain.No loosening nothing further to report.Affected side: left knee.
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 Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > according to the information provided, it was reported that the patient was revised due to pain.No loosening nothing further to report.Doi: unknown dor: (b)(6)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 = > 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.Added: d10 concomitant corrected: d3 manufacturer email.

• Brand Name: ATTUNE
• Common Device Name: Knee Implant - Tibial Insert
• Manufacturer (Section D): DePuy Ireland - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): Cork Mfg & Material Warehouse; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50913641
• Report Number: 1818910-2026-16658
• Device Sequence Number: 12094814
• Product Code: JWH
• UDI-Device Identifier: 10603295541837
• UDI-Public: (01)10603295541837(17)330531(10)M9428R
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K253197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 151820708
• Device Lot Number: M9428R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 8 POR; ATTUNE FEM POR CR LT SZ 7
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male