MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 5 CEM; KNEE FEMORAL

Catalog Number	150440105
Medical Device Problem Codes	Loss of or Failure to Bond (1068); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Subject id: (b)(6) study no: (b)(4).Clinical adverse event received for tibial and femoral component loosening on index knee device and procedure (relatedness) device related: possibly procedure related: definitely.Date of event: un jan 2025 date of implant: (b)(6) 2020 date of revision: no information provided device location: left.Treatment/impact: other: true.If other ¿ specify: planned to have revision surgery in (b)(6) of 2026.
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).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: d10 (concomitant).
Additional Manufacturer Narrative
Product complaint #(b)(4).Upon further review, it has been determined that this complaint was reported in error as it is duplicate of (b)(4).Further updates will only be provided on (b)(4).

• Brand Name: ATTUNE CRS FEMORAL LT SZ 5 CEM
• Common Device Name: KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23880545
• Report Number: 1818910-2025-22449
• Device Sequence Number: 9605195
• Product Code: JWH
• UDI-Device Identifier: 10603295042181
• UDI-Public: (01)10603295042181(17)290831(10)J48D18
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150440105
• Device Lot Number: J48D18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 03/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/24/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2021
• 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 DIST FEM AUG SZ 5 12MM; ATTUNE DIST FEM AUG SZ 5 12MM; ATTUNE POS FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM20X110MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 88 KG