MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE MED DOME PAT 41MM POR; KNEE IMPLANT - PATELLA

Catalog Number	151821041
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.Additional narrative: 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 that the packaging ripped and was deemed not sterile by doctor.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 352999 lot number, and no non-conformances nor manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history lot = > a manufacturing record evaluation was performed for the finished device 352999 lot number, and no non-conformances nor manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device 352999 lot number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: ATTUNE MED DOME PAT 41MM POR
• Common Device Name: KNEE IMPLANT - PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22326614
• Report Number: 1818910-2025-10484
• Device Sequence Number: 15823470
• Product Code: JWH
• UDI-Device Identifier: 10603295523635
• UDI-Public: (01)10603295523635(17)321130(10)352999
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K202194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151821041
• Device Lot Number: 352999
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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: Male