MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 7 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611007
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the attune size 7 cementless tibial tray was revised due to pain and a subsequent bone scan showed a ¿hot¿ spot on the posterior aspect of the tibial tray.The tray originally implanted in (b)(6) 2022.The knee was revised on (b)(6) 2024.No bone in growth or on growth evident on the tray when explanted and the tray was explanted quite easily.No bony evidence on the explanted tray.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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 that 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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received: "i wish to register a product complaint for an attune sz 7 cementless tibial tray which was revised last evening in the above hospital by prof.Please send in any relevant forms that need to be completed to begin the process.Tray originally implanted in (b)(6) 2022.Patient reported pain and the subsequent bone scan show a ¿hot¿ spot on the posterior aspect of the tibial tray.Knee was revised yesterday (b)(6) 2024.No bone in growth or on growth evident on the tray when explained and tray explained quite easily.No bony evidence on the explant tray.".The product was not returned to j&j medtech orthopaedics, however photos were provided for review.((b)(4) - product complaint (b)(6) - prof (b)(6) - attune cementless tibial tray and _external_ re_ (b)(4) additional information (3rd request)).The photo/x-ray investigation revealed signs of the device being implanted for a period of time and a minimum surface of bone still attached to the attune rp tib base sz 7 por surface.Taking in consideration the amount of bone attached to the implant, the reported condition can be confirmed.However, with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, 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.The overall complaint was confirmed as the observed condition of the attune rp tib base sz 7 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.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.

• Brand Name: ATTUNE RP TIB BASE SZ 7 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21047872
• Report Number: 1818910-2024-26206
• Device Sequence Number: 15553337
• Product Code: NJL
• UDI-Device Identifier: 10603295416296
• UDI-Public: (01)10603295416296(17)300331(10)9483329
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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,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: 150611007
• Device Lot Number: 9483329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 01/14/2025; 02/21/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/10/2025; 01/15/2025; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2020
• 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