MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611007
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
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.
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
It was reported that attune fem por cr lt sz 7, attune rp tib base sz 7 por, and attune cr rp insrt sz 7 5mm were involved in a reported event following a total knee arthroplasty.The patient presented over twelve months postoperatively with a painful knee and an audible click.Imaging revealed a dense mass in the center of the distal femur, and a knee scope was scheduled to further investigate, with the possibility of revision surgery.The event was identified during a follow-up clinic visit.The patient experienced pain and audible noise when walking, and additional medical interventions included ct imaging and a scheduled knee scope.
Event or Problem Description
Additional information received: a.Please provide the date of event.- patient presented in clinic for one year follow up.B.Please confirm whether the revision surgery completed on (b)(6) 2026? knee scope done on (b)(6).No evidence of anything in joint space.Revision surgery not required.C.Please confirm the availability of explants- discarded or still available? revision surgery not required, no explant.D.Ct scan- dense mass in the center of the distal femur - is this related to patient factors or implant related? what was surgeon's opinion? - surgeon is unclear what this was, or if it was metal artefact on image or if anything.Unable to see anything during knee scope.Patient was unable to reproduce "audible click" during clinic appts pre knee scope.Surgeon decided not to proceed with open surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5 corrected: h6 (health effect - impact code, medical device problem code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : 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: 25047344
• Report Number: 1818910-2026-07991
• Device Sequence Number: 16066631
• Product Code: NJL
• UDI-Device Identifier: 10603295416296
• UDI-Public: (01)10603295416296(17)340731(10)4507335
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 150611007
• Device Lot Number: 4507335
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/03/2026; 05/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/06/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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 CR RP INSRT SZ 7 5MM; ATTUNE FEM POR CR LT SZ 7
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male