MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT REV CONCENTRIC CONE LG; KNEE IMPLANT - REVISION CONE

Catalog Number	151404150
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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.A1: 01684-09468.
Event or Problem Description
Subject id: (b)(6) study no: oasis prod.Clinical adverse event received for revision ¿ aseptic loosening device and procedure (relatedness): device related: no information provided, procedure related: no information provided, date of event: no information provided, date of implant: no information provided, date of revision: (b)(6) 2025 device location: right.Treatment/impact: revision, anesthesia regional (spinal, epidural).Depuy synthes products used: catalog number: 152020706 lot number: m59r71 component type: insert description: attune right medial stabilized insert size 7 6mm.Catalog number: 545050501 lot number: 4473386 component type: cement description: smartset cement with gentamicin 40g.Catalog number: 151404150 lot number: 4112124 component type: cone description: revision concentric cone large.Catalog number: 151404150 lot number: 4112124 component type: cone description: revision concentric cone large.
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 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.

• Brand Name: ATT REV CONCENTRIC CONE LG
• Common Device Name: KNEE IMPLANT - REVISION CONE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21984206
• Report Number: 1818910-2025-07347
• Device Sequence Number: 14531066
• Product Code: JWH
• UDI-Device Identifier: 10603295520634
• UDI-Public: (01)10603295520634(17)330630(10)4112124
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• 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: 151404150
• Device Lot Number: 4112124
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 80 KG