MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410205
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
It was reported the packaging of the attune femur implant did not have the sticker tag that enables easy removal from the outer packaging into the sterile field.The implant was tipped into the sterile field.The procedure was completed successfully with no delay or patient consequences reported.Doi: (b)(6) 2025 affected side: right femur.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > the packaging of an attune femur was opened and did not have the usual sticker tag on the top of the packaging to enable easy removal into the sterile field from the outer packaging.As a result the staff had to tip the implant into the sterile field (however, some hospitals do have a 'no tipping' policy.See attached photos.Photos were provided for review.See attachment img_7758.Jpeg and img_7759.Jpeg.The depuy synthes team forwarded the photos of the complaint unit to the manufacturing site depuy cork for a manufacturing investigation.The photo investigation revealed that the tyvek lid does not contain the lift label, confirming the reported allegation.The assignable cause was deemed to be ¿material¿ as supplied by the supplier.This assignable cause is not associated with human error within operations under the control of depuy cork.There are no trends identified in the historical review of non-conformances which could be related to the failure mode of the complaint.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 5 cem would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a nr was created to address current complaint condition.

• Brand Name: ATTUNE PS FEM RT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23435174
• Report Number: 1818910-2025-18695
• Device Sequence Number: 17339158
• Product Code: JWH
• UDI-Device Identifier: 10603295041764
• UDI-Public: (01)10603295041764(17)331031(10)4331279
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150410205
• Device Lot Number: 4331279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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
• Patient Sex: Unknown