MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP TIB BASE SZ 4 CEM; KNEE TIBIAL TRAY

Catalog Number	150680004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Investigator initiated study (iis) (b)(6).Patient received attune implant as part of the study.Event: dvt calf r leg start date: (b)(6) 2024 / surgery date: (b)(6) 2024, event start date: (b)(6) 2024.As noted on site form: event did not occur at the operative site / the investigator opinion was the event was unanticipated, possibly related to the procedure and unrelated to the study device i.E.Attune implant / severity was listed as mild and considered serious.Us radiology confirmed dvt (b)(6) 2024, patient commenced on eliquis 5mg x 2 bd for 1-week / x1 bd for 2-weeks resolved review ultrasound (b)(6) 2024 outcome noted as 'resolved, no sequelae' patient was not withdrawn form the study as a result of this event.

• Brand Name: ATTUNE RP TIB BASE SZ 4 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 22117899
• Report Number: 1818910-2025-08811
• Device Sequence Number: 4122919
• Product Code: NJL
• UDI-Device Identifier: 10603295492160
• UDI-Public: (01)10603295492160(17)20330731(10)4252726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 150680004
• Device Lot Number: 4252726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female