MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE RP TIB BASE SZ 5 CEM; KNEE TIBIAL TRAY

Catalog Number	150680005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced attune tibia bone fracture on the right side.The femoral component was changed due to being loose.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: 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 recon described in this report.H11 additional narrative: added: b5, h6 medical device problem code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that the implants was discarded after sonication.It is not possible to have the implants back.On this case that have no sense the bone was the problem.
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, d10 (concomitant).Recaptured codes on h6 (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.
Event or Problem Description
Additional information received states that no infection, no allergies, and sonification is to make a culture to be sure their is no infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: attune tibia bone fracture.Right.We have to change the femur because it was loose.The product was not returned to depuy synthes; however, photos were provided for review.The photos and x-rays investigation revealed that the attune rp tib base sz 5 cem only displays sign of bone ingrowth at the fixation surface.Additionally, the tibia bone fracture can be observed, however, there is no evidence that the attune rp tib base sz 5 cem would have contributed to the reported allegation.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed as the observed condition of the attune rp tib base sz 5 cem would have not contributed to the complained device issue.Based on the investigation findings, and 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 depuy synthes 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 device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11.Additional narrative: added: h6.Medical device problem code.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: attune tibia bone fracture.Right.We have to change the femur because it was loose.The product was not returned to depuy synthes; however, photos were provided for review.The photos and x-rays investigation revealed that the attune rp tib base sz 5 cem only displays sign of bone ingrowth at the fixation surface.Additionally, the tibia bone fracture can be observed, however, there is no evidence that the attune rp tib base sz 5 cem would have contributed to the reported allegation.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The overall complaint was not confirmed as the observed condition of the attune rp tib base sz 5 cem would have not contributed to the complained device issue.Based on the investigation findings, and 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 depuy synthes 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 device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: h6 medical device problem code.

• Brand Name: ATTUNE RP TIB BASE SZ 5 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND; 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 ; 9083863534
• MDR Report Key: 23327947
• Report Number: 1818910-2025-17771
• Device Sequence Number: 13415852
• Product Code: NJL
• UDI-Device Identifier: 10603295492177
• UDI-Public: (01)10603295492177
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 150680005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 12/11/2025; 12/18/2025; 01/05/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/09/2025; 12/12/2025; 12/19/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 INSR SZ 6 8MM XLK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female