MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150610006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: d6a, h10: implant date and date of concomitant therapy is an unknown day in 2014.
Event or Problem Description
It was reported that the surgeon performed a revision of an attune crrp construct for loosening of tibial and femoral components.Tibia was loose at the implant/cement interface.Femur was loose as the cement/bone interface.Cement manufacturer was unknown.
Event or Problem Description
Additional information received stating no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: revision of an attune crrp construct for loosening of tibial and femoral components.Tibia was loose at the implant/cement interface.Femur was loose as the cement/bone interface.Unsure of the cement used.I¿m unable to confirm the lot number for the femoral component, but the product code is 150400206 attune cr 6 right cemented.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the attune rp tib base sz 6 cem had organic material on the surface.Although no signs of burnishing can be observed, the lack of cement remnants on the device might be an indicator of improper fixation between the cement and implant interface.A manufacturing record evaluation was performed for the finished device product code: 150610006 lot number: 8602616, and there were 2 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.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.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 6 cem 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: a manufacturing record evaluation was performed for the finished device product code: 150610006 lot number: 8602616, and there were 2 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.Device history review: a manufacturing record evaluation was performed for the finished device product code: 150610006 lot number: 8602616, and there were 2 non-conformances associated with this lot, however these are not related to the failure mode of the complaint.H11 additional narrative: added: b5.

• Brand Name: ATTUNE RP TIB BASE SZ 6 CEM
• Common Device Name: ATTUNE IMPLANT : 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: 21593106
• Report Number: 1818910-2025-03879
• Device Sequence Number: 8924791
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: (01)10603295042600(17)270731(10)8602616
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150610006
• Device Lot Number: 8602616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2017
• 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 FEM RT SZ 6 CEM; ATTUNE CR RP INSRT SZ 6 6MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male