MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
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: 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.
Event or Problem Description
Clinical adverse event received for periprosthetic femur fracture of r side (study side) device and procedure (relatedness): device related: possibly related, procedure related: possibly related, date of event: 10-mar-2022, date of implant: (b)(6) 2014, date of revision: no information provided, device location: right.Treatment/impact: hospitalization, results in a medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or function, surgical intervention not for the study knee (open reduction with internal fixation.Knee implant was not removed or revised.Depuy synthes products used: catalog number: 150410204, lot number: 390187, component type: femoral, description: attune post/stab fem rt, sz 4 cemented.Catalog number: 150610004, lot number: 3514793, component type: tibial, description: attune rp tibial sz 4, cemented.Catalog number: 151650407, lot number: 3461897, component type: insert, description: attune ps/rp insert sz 4, 7mm.Catalog number: 151820035, lot number: 6106976, component type: patellar, description: attune medial dome pat, 35mm.Catalog number: 61979001, lot number: mju094, component type: cement, description: simplex p bone cement, full dose.

• Brand Name: ATTUNE PS FEM RT SZ 4 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22035049
• Report Number: 1818910-2025-08003
• Device Sequence Number: 9504693
• Product Code: JWH
• UDI-Device Identifier: 10603295041757
• UDI-Public: (01)10603295041757(17)230531(10)390187
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,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 Expiration Date: 05/31/2023
• Device Catalogue Number: 150410204
• Device Lot Number: 390187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2013
• 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: Unknown