MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 5 CEM; KNEE TIBIAL TRAY

Catalog Number	150670005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2026
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.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 attune primary was put in a valgus knee.Tracking well on table but subluxes when patient flexes.Lateral side and patella fine, medial side - tibia moves anterior, femur posterior.Bearing looks seated on xr, sizes appropriate, no loose bodies seen.If went to revision could i use medial pivot bearing in the primary tibia with ps femur.Elderly low demand patient.No revision surgery planned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, it has been determined that there is no allegation against the device, no treatment provided, therefore no reportable event.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE FB TIB BASE SZ 5 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: 24443328
• Report Number: 1818910-2026-03666
• Device Sequence Number: 16007595
• Product Code: JWH
• UDI-Device Identifier: 10603295492078
• UDI-Public: (01)10603295492078(17)350930(10)4986813
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 150670005
• Device Lot Number: 4986813
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown