MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE REV LPS INSRT XXSM 16MM; KNEE TIBIAL INSERT

Catalog Number	151760116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
Patient was revised due to infection.Patient continues to drain after bilateral revision tkas for infection.Cultures from previous cases all show the same sensitive organism but drainage continues to occur even with complete implant exchange.A thorough i&d with poly exchanges were performed on both sides with placement of resorbable antibiotic beads without surgical delay or patient harm.Cultures were taken on both sides intraoperatively.Doi: (b)(6) 2025 dor: (b)(6) 2025 affected side: right knee.This report captures the right knee.The left knee is captured on related complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:151760116, lot:jn0951 and no non-conformances / manufacturing irregularities were identified.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 manufacturing record evaluation (nc search) was performed for the finished device product code:151760116, lot:jn0951 and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10.

• Brand Name: ATTUNE REV LPS INSRT XXSM 16MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND; 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: 21995817
• Report Number: 1818910-2025-07524
• Device Sequence Number: 4312006
• Product Code: KRO
• UDI-Device Identifier: 10603295491088
• UDI-Public: (01)10603295491088(17)260930(10)JN0951
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191779
• 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: Physician
• 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 Expiration Date: 09/30/2026
• Device Catalogue Number: 151760116
• Device Lot Number: JN0951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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: ATTUNE REV LPS INSRT XXSM 16MM; ATTUNE REV LPS INSRT XXSM 18MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG