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); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had knee replacements surgery in 2024 on both knees.Following the knee bilateral replacement procedure, the patient experienced a series of adverse events including infection, wound dehiscence, bleeding, allergic reaction to nickel, foreign body reaction, loss of range of motion, knee swelling, night sweats, scar tissue formation, and two falls.The infection required intravenous antibiotics, and allergy testing confirmed sensitivity to nickel.The patient continues to experience significant pain and has a revision planned for the right knee, with no plans for the left knee at this time.A successful bilateral total knee arthroplasty was performed using depuy synthes implants and competitor cement on (b)(6) 2024.No intraoperative complications were noted.
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.H11.Additional manufacturer narrative: h3, h6: 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.No device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.

• 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: 50055547
• Report Number: 1818910-2026-12828
• Device Sequence Number: 10539610
• Product Code: JWH
• UDI-Device Identifier: 10603295056683
• UDI-Public: (01)10603295056683(17)280731(10)4238882
• 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

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: 4238882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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