MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 7 6MM; KNEE TIBIAL INSERT

Catalog Number	151710706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	02/15/2020
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.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)(6).Clinical adverse event received for post-operative anemia device related: definitely not procedure related: definitely date of event: 15 feb 2020 date of implant: (b)(6) 202014 date of revision: no information provided device location: left.Treatment/impact: 2 x erythrocyte concentrate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H11 additional narrative: added: d10.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿clinical adverse event received¿.1)quantity manufactured: (b)(4).2)date of manufacture: 09/14/2019.3)any anomalies or deviations identified in dhr: two non-conformances were identified, however not related to the reported failure mode of the complaint.4)expiry date: 08/31/2024.5)ifu reference: ifu-0902-00-876.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: 1)quantity manufactured: (b)(4).2)date of manufacture: 09/14/2019.3)any anomalies or deviations identified in dhr: two non-conformances were identified, however not related to the reported failure mode of the complaint.4)expiry date: 08/31/2024.5)ifu reference: ifu-0902-00-876.Corrected: h4.

• Brand Name: ATTUNE CRS RP INSRT SZ 7 6MM
• 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 dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23368131
• Report Number: 1818910-2025-18025
• Device Sequence Number: 13041245
• Product Code: NJL
• UDI-Device Identifier: 10603295056126
• UDI-Public: (01)10603295056126(17)240831(10)9274059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 151710706
• Device Lot Number: 9274059
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 12/17/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/06/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2019
• 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 CEMENTED STEM 16X80MM; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE MEDIAL DOME PAT 41MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR (OTIPAC 80 REFOBACIN BONE CEMENT R); COMPETITOR CEMENT (PALACOS R+G 2X20); COMPETITOR PRODUCT (TEKNIMED.); COMPETITOR(OTIPAC 60 REFOBACIN BONE CEMENT R)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown