MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Attune Implant : Knee Tibial Insert

Catalog Number	151650610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Loss of Range of Motion (2032)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of an attune psrp construct was done due to patella and femoral component loosening.Tibia was well fixed, but was explanted.No allegation made against the poly.Bone scans showed a ¿hot¿ patella and femoral component indicating loosening.The patient had struggled with the knee from the beginning, and then started regressing.Their leg was very stiff and had poor rom.All components were removed and attune revision was implanted.Surgeon uses cmw2 cement.Suspected cement-bone interface as components came out with cement on them.Side affected: left side.
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.

• Brand Name: ATTUNE
• Common Device Name: Attune Implant : Knee Tibial Insert
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50858150
• Report Number: 1818910-2026-16389
• Device Sequence Number: 10026008
• Product Code: NJL
• UDI-Device Identifier: 10603295052609
• UDI-Public: (01)10603295052609(17)250930(10)9607394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 09/30/2025
• Device Catalogue Number: 151650610
• Device Lot Number: 9607394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2020
• 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