MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATUNE CRS FB TIB BASE SZ 4 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150640004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
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.Additional narrative: 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
Subject id: (b)(6), study no:(b)(6).Clinical adverse event received for no information provided dclinical adverse event received for left knee oedema device related: remote possibility procedure related: definitely.Treatment/impact: other (drainage) depuy synthes products used: catalog number: 150440106 lot number: j0841j component type: femoral component description: attune revision crs femoral size 6 left cemented.Catalog number: 150640004 lot number: 9640684 component type: tibial base component description: attune revision tibial base fixed bearing size 4 cemented.Catalog number: 151700608 lot number: h80128 component type: tibial insert component description: attune revision crs fixed bearing insert size 6 8 mm.Catalog number: 66017750 lot number: 95654956 component type: cement description: heraeus medical gmbh palacos cement.Catalog number: 66017750 lot number: 95904875 component type: cement description: heraeus medical gmbh palacos cement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform 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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Added: d10 (concomitant).

• Brand Name: ATUNE CRS FB TIB BASE SZ 4 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24159596
• Report Number: 1818910-2026-01370
• Device Sequence Number: 9000611
• Product Code: JWH
• UDI-Device Identifier: 10603295042785
• UDI-Public: (01)10603295042785(17)301031(10)9640684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Non-Healthcare 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: 150640004
• Device Lot Number: 9640684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2021
• 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 CRS FB INSRT SZ 6 8MM; ATTUNE CRS FEMORAL LT SZ 6 CEM; UNK BONE CEMENT (COMPETITOR PRODUCT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown