MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 8 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611008
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced a postoperative event.Attune tibia cementless break-down, right-side.There was no surgical delay.There was no patient consequence.Implant date: (b)(6) 2023.Explant date: (b)(6) 2025.Affected side: right side.
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.H3, h6: a search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.The product was not returned to j&j medtech orthopaedics, however photos were received for review.The photo/x-ray investigation revealed organic debris over the attune rp tib base sz 8 por's surface.However, no signs of significant bone ingrowth was observed on the implants surface.The lack of bone remnants attached to the device fixing surface, might be an indicator of improper fixation between the bone and the implant interface.However, consideration must be given to all other potential influences such as patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A search of the medtech nonconformance (nc) quality system found no nc's associated with this product/lot combination.The overall complaint was confirmed as the observed condition of the attune rp tib base sz 8 por would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: ATTUNE RP TIB BASE SZ 8 POR
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21721081
• Report Number: 1818910-2025-04709
• Device Sequence Number: 13120987
• Product Code: NJL
• UDI-Device Identifier: 10603295416302
• UDI-Public: (01)10603295416302(17)20320930(10)3980078
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150611008
• Device Lot Number: 3980078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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 MEDIAL DOME PAT 41 MM; ATTUNE MEDIAL DOME PAT 41 MM; ATTUNE PS RP INSRT SZ8 6 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male