MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FB INSRT SZ 3 12MM; KNEE TIBIAL INSERT

Catalog Number	151700312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2021
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.Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6), study no: (b)(6).Clinical adverse event received for persistent pain in left knee.Event is not serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021 date of event: 01 dec 2021 (left knee).Treatment: oral medication and diagnostic intervention treatment/impact: injected medication.Depuy products used (no revision completed): device log form log line: 1 component type: femoral component catalog number: 150440103 lot number id: jc2497 device identifier: (b)(4).Device log form log line: 2 component type: tibial base component catalog number: 150640003 lot number id: 9773729 device identifier: (b)(4).Device log form log line: 3 component type: tibial stem catalog number: 151214030 lot number id: d21063066 device identifier: (b)(4).Device log form log line: 4 component type: tibial insert component catalog number: 151700312 lot number id: j03p07 device identifier: (b)(4).Device log form log line: 5 component type: cement catalog number: 66017750 lot number id: 97671012 device identifier: (b)(4).Device log form log line: 6 component type: cement catalog number: 66017750 lot number id: 97714988 device identifier: (b)(4).

• Brand Name: ATTUNE CRS FB INSRT SZ 3 12MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: elba bello ; 700 orthopaedic drive; warsaw, IN 46582 ; 9083863534
• MDR Report Key: 23310112
• Report Number: 1818910-2025-17655
• Device Sequence Number: 5788696
• Product Code: JWH
• UDI-Device Identifier: 10603295054610
• UDI-Public: (01)10603295054610
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 151700312
• Device Lot Number: J03P07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 54 KG