MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM16X60MM; KNEE STEMS

Catalog Number	151316060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	07/18/2025
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.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 despite repeated attempts to cure the systemic infection this patient had, patient continued to show infection and it was decided to remove the implants in his right leg and perform an above knee amputation.All components performed as expected to there was no allegation against the components.This submission is being made as the implants were removed.Doi: (b)(6) 2025.Dor: (b)(6) 2025.Affected side: right knee.
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 that 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: added: h6 health effect clinical code.If information that was not available for the initial report is obtained, 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.A search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<151316060>/lot 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 medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<151316060>/lot combination.H11 additional narrative: added: d10.

• Brand Name: ATUNE PRESSFIT STR STEM16X60MM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22688966
• Report Number: 1818910-2025-13525
• Device Sequence Number: 8959047
• Product Code: JWH
• UDI-Device Identifier: 10603295043669
• UDI-Public: (01)10603295043669(17)350131(10)D25013754
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 151316060
• Device Lot Number: D25013754
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/09/2025; 08/22/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/14/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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 +5; ATUN FEM SLV M/L 30MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; CONTROL CABLE W/CABLE SLEEVE; LPS CEM FEM STEM 11X150MM BOW; LPS INTERCALARY SEGMENT 55MM; LPS SEGMENTAL COMPONENT 65MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG