MAUDE Adverse Event Report: DePuy Ireland - 9616671 ATTUNE; Attune Cementless Implants : Knee Tibial Tray

Catalog Number	150611006
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent an endo genus dextri (right side) - attune cementless surgery on (b)(6) 2024.After the surgery, they experienced constant pain and had an unsteady gait.According to product specifications, when properly implanted, the components fuse with the bones of the knee within eight weeks.Following examinations and imaging studies, it was determined that the joint components were not in place; the patella was outside the femoral groove of the joint (patela bata), and the leg had been displaced to the right and outward.The surgeon recommended physical therapy, but the problem was not resolved.They then recommended operation only on the knee cap.After consultations with other orthopedic surgeons and imaging studies, it was determined that the patella (kneecap) and the joint were not aligned.The joint had been positioned further inward, while the patella was 1 cm to the right and did not fit into the femoral canal.Revision surgery occurred on (b)(6) 2025, fourteen months after initial endoprosthesis replacement.It was determined that osseointegration had not occurred.There was no sign of bone on the implants; they were removed extremely easily, and they were removed on the first attempt.
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.

• Brand Name: ATTUNE
• Common Device Name: Attune Cementless Implants : Knee Tibial Tray
• Manufacturer (Section D): DePuy Ireland - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50037061
• Report Number: 1818910-2026-12720
• Device Sequence Number: 13393647
• Product Code: NJL
• UDI-Device Identifier: 10603295416289
• UDI-Public: (01)10603295416289(17)340228(10)4427559
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150611006
• Device Lot Number: 4427559
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/07/2026; 09/30/2026; 10/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/03/2026; 09/14/2026; 10/01/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2024
• 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 PS RP INSRT SZ7 5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 195 LB