MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 6 16MM; KNEE FEMORAL ACCESSORY

Catalog Number	154706004
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised due to femur being loose.The loosening interface was cement bone interface.There was no surgical delay.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).It was reported that the femoral adaptors were not loose.Upon further review, it has been determined that mwr 1818910-2025-03121 under (b)(4) has been submitted in error.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE DIST FEM AUG SZ 6 16MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21472322
• Report Number: 1818910-2025-03121
• Device Sequence Number: 8749506
• Product Code: JWH
• UDI-Device Identifier: 10603295382805
• UDI-Public: (01)10603295382805(17)300731(10)J86Y15
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 154706004
• Device Lot Number: J86Y15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2020
• 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: 63 YR
• Patient Sex: Female