MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number	151820035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presents in clinic with what appears to be a loose patellar component and is scheduled to revise.Xrays appear to show significant bone loss of patella.Operatively, patellar component with cement still attached is loose and patellar bone has resorbed.Essentially only a cortical shell is remaining.Surgeon notes this is a the first time in his 30 year career he has encountered this finding.A competitive implant is sewn into the existing bone, which is minimal at best, along with native soft tissue.Surgeon routinely utilizes depuy 2 cement for his primary knee replacements, but is hospital owned so no lot information is available.This is stored at the facility and hand mixed in an open bowl.That is the only information that is available.Cemented femoral and tibial components are found to be well fixed, and the same batches of cement were utilized to cement all 3 components.No patient harm nor delay is noted.There was a patella loosening at bone/cement interface.Cement manufacturer is depuy.Doi: (b)(6) 2024, dor: (b)(6) 2025, affected side: right knee.
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.H3, h4, h6 investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• 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: 22125124
• Report Number: 1818910-2025-08873
• Device Sequence Number: 17960407
• Product Code: JWH
• UDI-Device Identifier: 10603295056683
• UDI-Public: (01)10603295056683(10)D24021574
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151820035
• Device Lot Number: D24021574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG