MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FEM POR CR LT SZ 3; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150401103
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the attune cementless cr size 3 left femoral component porocoat coating faulty.The porocoat coating had visible cracking on the anterior chamfer region.Surgeon noticed the defect and it was not implanted.Surgery was delayed 3 minutes due to the reported event.
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.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 : attune cementless cr size 3 left femoral component porocoat coating faulty.The porocoat coating had visible cracking on the anterior chamfer region.Surgeon noticed the defect and it was not implanted.The devices associated with this report were returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to the manufacture site which conducted a visual inspection of the returned device.The investigation performed by the manufacture site confirmed there was "separation", defined as, lines on the porous surface where consecutive beads have not been sintered together, giving the appearance of "cracks" in the porocoat surface of the femoral component.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune fem por cr lt sz 3 would contribute to the complained device issue.Based on the assessment of the current complaint unit condition against the required manufacturing specifications, the complaint unit failed the inspection criteria.Root cause was traced to human error at the manufacture site during application of porous coating.Therefore, the manufacturing issue has been addressed in the depuy synthes quality system to further investigate the confirmed nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : an nr was created to address current complaint condition.
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.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 states that there was no patient harm related to the event.

• Brand Name: ATTUNE FEM POR CR LT SZ 3
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19039890
• Report Number: 1818910-2024-07520
• Device Sequence Number: 17980602
• Product Code: MBH
• UDI-Device Identifier: 10603295041320
• UDI-Public: 10603295041320
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/04/2024

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: 150401103
• Device Lot Number: 8922032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 07/10/2024; 07/10/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/24/2024; 07/10/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2018
• 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