MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	01/01/2024
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for sepsis.Device relatedness: no information provided.Procedure relatedness: no information provided.Date of event: unk dec 2024.Date of implant: (b)(6) 2019.Date of revision : no information provided.Device location: right.Treatment/impact: injected medication.
Additional Manufacturer Narrative
Product complaint (b)(4).New information was received from the clinical site, which indicated that clinical site determined that the adverse event (ae) was not related to device and was not related to procedure.Does not meet the definition of a complaint.Information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy device after it was released for distribution.There is no report of an adverse event involving a depuy device.Clinical database indicates ae is not related to device or procedure.

• Brand Name: ATTUNE PS RP INSRT SZ 8 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 20333265
• Report Number: 1818910-2024-20425
• Device Sequence Number: 15448453
• Product Code: NJL
• UDI-Device Identifier: 10603295052869
• UDI-Public: (01)10603295052869(17)230630(10)8839360
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 06/30/2023
• Device Catalogue Number: 151650807
• Device Lot Number: 8839360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 78 KG