MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE; KNEE STEMS

Catalog Number	151316060
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
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.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that the patient had rt tka revision (b)(6) 2026.During proper preparation and successful trialing of femoral and tibial implants, during femoral implantation the implant would not fully seat.Multiple attempts were made including re-broaching and reaming of the femoral canal and implant would not sit where femoral trials were prepped.Surgeon decided to convert to a cone and stem construct and not use the femoral implant with sleeve.This lengthened the case ~15-20 minutes as we needed to re-prep and build new femoral construct.Affected side: right knee.

• Brand Name: ATTUNE
• Common Device Name: KNEE STEMS
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25748771
• Report Number: 1818910-2026-11610
• Device Sequence Number: 21435811
• Product Code: JWH
• UDI-Device Identifier: 10603295043669
• UDI-Public: (01)10603295043669(17)360131(10)d26015202
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K241000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: 151316060
• Device Lot Number: D26015202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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