MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM14X60MM; KNEE STEMS

Catalog Number	151314060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 the patient presents with infection post spacer.However, patient now presents with a fungal infection.All components performed as expected and were well fixed, however had to be removed to treat this new finding.All components were successfully removed, and after a thorough debridement, the bone was prepared for new components.During debridement, a vessel was perforated due to scar tissue and was repaired operatively.The surgeon stated this to be a common occurrence due to the location of debridement anatomically and was expected and prepared for.This resulted in a short delay while the repair took place.New components were placed uneventfully for a new spacer, along with placement of antibiotic beads, antifungal beads and high dose antibiotic cement.Doi: (b)(6) 2025.Dor: (b)(6) 2026.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A search of the depuy synthes (nc) quality system found no nc¿s associated with this product/lot (product code: 151314060, lot - d25031659) combination.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 a search of the depuy synthes (nc) quality system found no nc¿s associated with this product/lot (product code: 151314060, lot - d25031659) combination.Added: d10 concomitant.

• Brand Name: ATUNE PRESSFIT STR STEM14X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24162435
• Report Number: 1818910-2026-01401
• Device Sequence Number: 15710621
• Product Code: JWH
• UDI-Device Identifier: 10603295043607
• UDI-Public: (01)10603295043607(17)350228(10)D25031659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151314060
• Device Lot Number: D25031659
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATT REV SLV LPS FEM ADP +10; ATT REV SLV LPS FEM ADP +5; ATUN FEM SLV M/L 30MM FULL POR; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM12X110MM; CONTROL CABLE W/CABLE SLEEVE; LPS INTERCALARY SEGMENT 55MM; LPS SEGMENTAL COMPONENT 65MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 104 KG