MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410125
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon refused due to packaging malfunction.The outer packaging stuck to inner packaging and ripped when it was being opened.
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 = > it was reported that surgeon refused due to packaging malfunction.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded to the manufacturing site j&j medtech cork.Visual analysis of the returned device revealed that the blister package of the attune ps fem lt sz 5 nar cem was slight curling from the sides.The returned unit did not contain the inner packaging or both inner and outer tyvek lid.A manufacturing record evaluation was performed for the finished device product code: 150410125 lot number: 4544333, and no non-conformances or manufacturing irregularities were identified.Based on the manufacturing investigation, the outer blister seal adhesive transfer from the tyvek lid was 95% or above.This meets the production/manufacturing standard.Additionally, it was observed slight curling on three flanges, which were measured and met the required production/manufacturing standard.A review of the returned unit indicated that the outer packaging passed inspection standards.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune ps fem lt sz 5 nar cem would not have contributed to the complained issue.Based on the investigation findings, 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 j&j 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 manufacturing record evaluation was performed for the finished device product code: 150410125 lot number: 4544333, and no non-conformances or manufacturing irregularities were identified.Corrected: h3.

• Brand Name: ATTUNE PS FEM LT SZ 5 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 22122635
• Report Number: 1818910-2025-08853
• Device Sequence Number: 17936006
• Product Code: JWH
• UDI-Device Identifier: 10603295041702
• UDI-Public: (01)10603295041702(17)350228(10)4544333
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 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: 150410125
• Device Lot Number: 4544333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2025
• 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 Age: 75 YR
• Patient Sex: Unknown