MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 8; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150411208
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	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the attune femoral porocoat posterior stabilised, size 8, right, cementless, definitive implant and plastic containers were stuck together.Surgeon had to use a scalpel to cut through the sterile paper to get the implant out.Surgery was delayed by two minutes, and the procedure was completed successfully.There was no patient consequence.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received: "opening definitive implant and plastic containers were stuck together.Had to use a scapel to cut through the sterile paper to get the implant out.Attune femoral porocoat posterior stabilised.Size 8.Right.Cementless.Material 1504-11-208.Lot 4427799.Production date 28.03.2024.Expiry 28.02.2034".The product was not returned to j&j medtech orthopaedics, however photos were provided for review.Photo investigation revealed both blister packaging were deformed/warped and that the white protective material was stick to the tyvek lid.Based on the observed conditions of the device packaging, it is reasonable to confirm that the user had difficulty while opening it.Although the packaging is observed in a deformed/warped condition, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other j&j controlled facilities through which finished goods are distributed.Once the product leaves j&j medtech orthopaedics control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of j&j medtech orthopaedics control.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune fem por ps rt sz 8 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ATTUNE FEM POR PS RT SZ 8
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21586976
• Report Number: 1818910-2025-03851
• Device Sequence Number: 8757329
• Product Code: MBH
• UDI-Device Identifier: 10603295042075
• UDI-Public: (01)10603295042075(17)340228(10)4427799
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 150411208
• Device Lot Number: 4427799
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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: Unknown