MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE; KNEE FEMORAL ACCESSORY

Catalog Number	154705001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/01/2018
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 narrative: h3, h6: 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.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
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for fracture (medial femoral condyle), device and procedure (relatedness), device related: possibly, procedure related: definitely, date of event: 01 mar 2018, date of implant: on (b)(6) 2018, date of revision: no information provided, device location: right, treatment/impact: none: yes, depuy synthes products used: catalog number: 66017569, lot number: 87094695, component type: cement, description: no information provided, catalog number: 150440205, lot number: hc1433, component type: femoral component, description: attune knee system revision crs femoral cemented right size 5, catalog number: 151216080, lot number: h44164, component type: femoral stem, description: attune knee system revision cemented stem 16x80mm, catalog number: 151820038, lot number: 8695634, component type: patella, description: attune patella medialized dome 38mm cemented aox, catalog number: 150640004, lot number: 8641298, component type: tibial base component, description: attune knee system revision fixed bearing tibial base cemented size 4, catalog number: 151700512, lot number: h66856, component type: tibial insert component, description: attune knee system revision crs fixed bearing insert aox 12mm size 5, catalog number: 151304000, lot number: 8602983, component type: tibial stem offset adaptor, description: attune knee system revision offset stem adaptor 4mm, catalog number: 151316060, lot number: h28305, component type: tibial stem, description: attune knee system revision pressfit stem 16x60mm, catalog number: 154705001, lot number: hh4409, component type: femoral lateral distal augment, description: attune knee system revision distal femoral augment 4mm cemented size 5, catalog number: 154905002, lot number: hh2641, component type: femoral medial posterior augment, description: attune knee system revision posterior femoral augment 8mm cemented size 5, catalog number: 154905002, lot number: hj2660, component type: femoral lateral posterior augment, description: attune knee system revision posterior femoral augment 8mm cemented size 5.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.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: d4 (lot) d10 concomitant.Corrected: d4 (primary udi number).

• Brand Name: ATTUNE
• Common Device Name: KNEE FEMORAL ACCESSORY
• 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: 24802033
• Report Number: 1818910-2026-06252
• Device Sequence Number: 9469796
• Product Code: JWH
• UDI-Device Identifier: 10603295382744
• UDI-Public: (01)10603295382744(10)0005444274
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• 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 Catalogue Number: 154705001
• Device Lot Number: 0005444274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• 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 KNEE SYSTEM REVISION POSTERIOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 81 KG