MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ATTUNE; Attune Implant : Knee Patella

Catalog Number	151820035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fall (1848); Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Loss of Range of Motion (2032); Distress (2329); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that unknown knee femoral, unknown knee tibial tray, and unknown knee tibial insert were involved in a knee replacement event.The patient experienced multiple complications following bilateral knee replacement surgery, including infection, wound dehiscence, bleeding, allergic reaction to nickel, foreign body reaction, hair loss, loss of range of motion, knee swelling, night sweats, scar tissue formation, and falls.The patient required intravenous antibiotics and underwent allergy testing, confirming nickel sensitivity.A successful bilateral total knee arthroplasty was performed using depuy synthes implants and competitor cement on (b)(6) 2024 this report is for the 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.

• Brand Name: ATTUNE
• Common Device Name: Attune Implant : Knee Patella
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• 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: 50055409
• Report Number: 1818910-2026-12827
• Device Sequence Number: 9491193
• Product Code: JWH
• UDI-Device Identifier: 10603295056683
• UDI-Public: (01)10603295056683(17)280831(10)4281187
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151820035
• Device Lot Number: 4281187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 09/09/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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 Age: 70 YR
• Patient Sex: Female