MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150401107
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
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
It was reported that there was a defect on a attune femur implant.A new implant was implanted.The procedure was successfully completed with no surgical delay.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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected: h6 (medical device problem code).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 no device associated with this report was received for examination.Product description: - attune fem por cr lt sz 7 product code:- 150401107 lot no:- 4788747 quantity of manufactured:- (b)(4) date of manufacturing:- 03-may-2025 expiry date:- 30-apr-2035.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot product description:- attune fem por cr lt sz 7 product code:- 150401107 lot no:- 4788747 quantity of manufactured:- (b)(4) date of manufacturing:- 03-may-2025 expiry date:- 30-apr-2035.Device history review a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: h4.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: defect on an attune femur implant.A new implant was implanted.Additional information received; the implant were not implantes.It was substituted with a new one.The product was not returned to depuy synthes; however, photos were provided for review.See attachment "attune_femurs defect_1 and attune_femurs defect_2".Additionally, all the available evidence was forwarded to the manufacturing site for further evaluation.The photo investigation revealed that the attune fem por cr lt sz 7 is placed in its inner opened tray.Also, device shows a dent at one condyle.A manufacturing investigation was performed with the following results; the complaint is confirmed.Based on the assessment of the current condition of the complaint photos against the required specifications, the complaint unit is deemed unacceptable.There are no trends identified in the historical review which could be related to the failure mode of the complaints.The complaint failure mode concerned surface finish - irregular/rough/dented.The assignable cause was due to missed inspections in the process.This was attributed to a human error-related issue.There is no expected impact on the sterility of unit, or the integrity of sterile barrier based on the complaint investigation.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 cr lt sz 7 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 manufacturing record evaluation was performed for the finished device 4788747 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.However, an nc was raised to address the reported complaint condition.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, prt 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.Was this defect in the attune femur implant identified prior to implantation? yes.The implant were not implanted.It was substituted with a new one.Was this the same patient that they have mentioned in question two as it is the same hospital.No, two different cases.B.Considering the second incident with the same device/lot combination within a short period of time: was a possible correlation within the lot size of 12 pieces checked? your ref: (b)(4)/(b)(4) / our ref: vk_20250902_12 -> revision case because of infection.Your ref.: (b)(4)/(b)(4) / our ref.: vk_20250909_32 -> defect in primary attune implants.

• Brand Name: ATTUNE FEM POR CR LT SZ 7
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23028030
• Report Number: 1818910-2025-15731
• Device Sequence Number: 9427878
• Product Code: MBH
• UDI-Device Identifier: 10603295041368
• UDI-Public: (01)10603295041368(17)350430(10)4788747
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,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: 150401107
• Device Lot Number: 4788747
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 11/18/2025; 12/04/2025; 01/27/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/03/2025; 11/19/2025; 12/05/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2025
• 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 Sex: Unknown