MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM14X60MM; KNEE STEMS

Catalog Number	151314060
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for knee revision ¿ aseptic loosening device related: no information provided.Procedure related: no information provided.Date of event: 20 oct 2025 date of implant: (b)(6) 2014 date of revision: (b)(6) 2025 device location: right.Treatment/impact: revision - components removed (femoral, insert, tibial, true), synovectomy.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 performed.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.H11 additional narrative: added: d4 (expiration date) and d10.Corrected: d4 (udi).

• Brand Name: ATUNE PRESSFIT STR STEM14X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23547685
• Report Number: 1818910-2025-19808
• Device Sequence Number: 9283983
• Product Code: JWH
• UDI-Device Identifier: 10603295043607
• UDI-Public: (01)10603295043607(17)350331(10)D25040366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 151314060
• Device Lot Number: D25040366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: 154907001; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 12MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN TIB SLV M/L 37MM FULL; ATUNE REV RP TIB BASE SZ 6 CE; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 112 KG